Clearly this was physician error and not device related...

ACCLARENT, INC. RELIEVA SPIN BALLOON SINUPLASTY SYSTEM SINUS BALLOON CATHETER Back to Search Results Catalog Number RS0616F Device Problem No Known Device Problem Event Date 09/16/2014 Event Type Injury
Event Description Acclarent was informed of an event that occurred during a procedure in which a reliev a spin balloon sinuplasty system and traditional rigid instruments, including an unidentified freer-elevator device were used. The procedure was said to involve bilateral frontal, maxillary and sphenoid sinus dilation. A preoperative ct scan had been performed which reportedly identified no skull base defect. Following dilation of both frontal and maxillary sinuses, and one sphenoid sinus, the physician began dilating the second sphenoid sinus. During dilation, the physician reported having observed clear fluid leaking from the patient's nose, and identified a csf leak from the area of the cribriform plate. The patient was transferred to a local hospital via ambulance where a subsequent ct scan identified a skull base defect. The patient was taken to the operating room where the attending surgeon reportedly identified the cerebrospinal fluid leak in the patient's sphenoid sinus, and the leak was repaired under general anesthesia. Sometime thereafter, the patient reportedly experienced a "cerebrovascular accident", which the surgeon reported most likely related to spasm of regional blood vessels. Acclarent followed up with the user facility and was informed tha the patient was released from the hospital and is doing well.

Manufacturer Narrative The device referenced in this report was discarded by the user facility and was not available for evaluation. Review of manufacturing records associated with the subject device did not detect any anomalies. The physician reported having no difficulties in using the acclarent device during or after the procedure. The extent to which the subject device caused or contributed to the reported event cannot be determined. If additional info is received regarding this report, a supplemental report will be filed. Acclarent will continue to monitor this phenomenon for trending purposes.

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Maybe Acclarent can install some SedaSys machines in a few of the Texas Whorehouses to help administer the propofol for the RARS 6 pack

Now that is the new acclarent six pack.

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I noticed a couple of posts were removed. It seems to be about the same people. Just a hat tip to the site owners, everything that has been said is true so they can't sue you and win. These peoples actions have caught up with them and now they're back peddling and trying to censor the actual truth. Free speech and it is the truth to boot!

I say truth to boot mother fuckers! I slammed my rep network partners up the ***!!!

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I noticed a couple of posts were removed. It seems to be about the same people. Just a hat tip to the site owners, everything that has been said is true so they can't sue you and win. These peoples actions have caught up with them and now they're back peddling and trying to censor the actual truth. Free speech and it is the truth to boot!

F them.

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Oh my...

I noticed a couple of posts were removed. It seems to be about the same people. Just a hat tip to the site owners, everything that has been said is true so they can't sue you and win. These peoples actions have caught up with them and now they're back peddling and trying to censor the actual truth. Free speech and it is the truth to boot!

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Did they bill the 31296-50, 31295-50-51, and 31297-50-53. Texas Tea = Propofol image

Oh my...

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WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

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I wonder what region that was in...many conversations about trying to have a patient do conscious sedation in a surgery center to cut costs and improve margin for the facility. Great business idea that led to a patient death.

I will give you my favorite piece of furniture if you don't post anything else about doing cases under conscious sedation in an ASC to cut down on costs.

-Bridget

image

Did they bill the 31296-50, 31295-50-51, and 31297-50-53. Texas Tea = Propofol image

This could be the best message post I've ever read.

Texas Tea!?!!?

Maybe Acclarent can install some SedaSys machines in a few of the Texas Whorehouses to help administer the propofol for the RARS 6 pack

post

WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

image

I wonder what region that was in...many conversations about trying to have a patient do conscious sedation in a surgery center to cut costs and improve margin for the facility. Great business idea that led to a patient death.

I will give you my favorite piece of furniture if you don't post anything else about doing cases under conscious sedation in an ASC to cut down on costs.

-Bridget

image

Did they bill the 31296-50, 31295-50-51, and 31297-50-53. Texas Tea = Propofol image

This could be the best message post I've ever read.

Texas Tea!?!!?

post

WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

image

I wonder what region that was in...many conversations about trying to have a patient do conscious sedation in a surgery center to cut costs and improve margin for the facility. Great business idea that led to a patient death.

Did they look into this? Unbelievable that JNJ continues to let this happen.

Any more on the patient who died? Territory? I guess firing 1/2 the salesforce has kept everyone distracted from a lil thing like patient death.

post

WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

image

I wonder what region that was in...many conversations about trying to have a patient do conscious sedation in a surgery center to cut costs and improve margin for the facility. Great business idea that led to a patient death.

I will give you my favorite piece of furniture if you don't post anything else about doing cases under conscious sedation in an ASC to cut down on costs.

-Bridget

image

Did they bill the 31296-50, 31295-50-51, and 31297-50-53. Texas Tea = Propofol image

post

WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

image

I wonder what region that was in...many conversations about trying to have a patient do conscious sedation in a surgery center to cut costs and improve margin for the facility. Great business idea that led to a patient death.

I will give you my favorite piece of furniture if you don't post anything else about doing cases under conscious sedation in an ASC to cut down on costs.

-Bridget

image

post

WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

image

I wonder what region that was in...many conversations about trying to have a patient do conscious sedation in a surgery center to cut costs and improve margin for the facility. Great business idea that led to a patient death.

Did they look into this? Unbelievable that JNJ continues to let this happen.

post

WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

image

I wonder what region that was in...many conversations about trying to have a patient do conscious sedation in a surgery center to cut costs and improve margin for the facility. Great business idea that led to a patient death.

Another unnecessary death with blood on JNJ's hands for encouraging unethical & illegal behavior and the DOJ's hands as they continue to allow this company to operate without forcing any accountability. Anyone know if the surgeon owned part of the surgery center?

post

WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

image

I wonder what region that was in...many conversations about trying to have a patient do conscious sedation in a surgery center to cut costs and improve margin for the facility. Great business idea that led to a patient death.

post

WTF! They were doing BSP under conscious sedation and the patient died? How hasn't this been discussed more???

image

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