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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL

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COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, DILATOR, ESOPHAGEAL Back to Search Results
Catalog Number HBD-W-15-16.5-18
Device Problems Hole In Material; Use of Device Problem
Event Date 12/28/2016
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: boston scientific's alliance ii inflation device. Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described. When the device was received the catheter was broken into two pieces. The device was cut at 72. 1 cm from the distal end of the proximal hub. No section of the catheter appeared to be missing. The stylet wire was included in the return. Due to the break in the catheter, the balloon material was not able to be tested. A visual inspection of the balloon material did not exhibit a rupture or split type leak. The location of the leak is unknown. No section of the balloon material appeared to be missing. There was a white substance on the exterior of the catheter that could possibly be contrast. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation. A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product. The additional information provided indicated the balloon dilator did not receive negative pressure prior to advancement through the endoscope. This is the most likely cause for the reported observation. The instructions for use direct the user "to facilitate passage through the endoscope, apply negative pressure to the device. " the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement. Negative pressure will also aid in balloon preservation and optimize balloon performance. A possible contributing factor to balloon damage is inadequate lubrication of the balloon with a lubricating agent. The instructions for use direct the user to "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel. " this activity will aid in endoscopic advancement and balloon preservation. Damage to the balloon material can occur if the balloon is inflated prior to advancement through the endoscope or if the balloon is inflated while partially or fully inside the accessory channel of the endoscope. The instructions for use contain the following precaution: ¿do not pre-inflate the balloon. ¿ the instructions for use direct the user to ensure the balloon is completely visualized and positioned before inflation. The instructions for use contain the following warning: ¿during dilation, do not inflate balloon beyond the maximum indicated inflation pressure. ¿ over inflation can cause damage to the balloon dilator. Another possible contributing factor is using a compromised inflation device to inflate the balloon. If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in damage to the balloon material. Prior to distribution, all hercules 3 stage wireguided balloon esophageal-pyloric-colonic are subjected to a visual examination to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available. Additional comments regarding this report: based on the information provided that negative pressure was not applied during advancement of the device through the endoscope channel, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

 
Event Description

During an esophageal dilation procedure, the physician used a cook a hercules 3 stage wireguided balloon esophageal-pyloric-colonic. The user deflated the balloon at the target site without problem [after first dilation], then he retracted the balloon into the endoscope to check the target site. Then he advanced the device again to the target site and attempted to inflate the balloon once more but found leakage from the balloon. He determined the target site was dilated enough and completed the procedure without additional dilation. The balloon would not deflate enough to retract into the endoscope, so the user removed the endoscope with the balloon catheter inside from the patient, and then he cut the sheath off and pulled the balloon out from the endoscope tip.

 
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Brand NameHERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
Type of DeviceKNQ, DILATOR, ESOPHAGEAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem , NC 27105
3367440157
MDR Report Key6286047
Report Number1037905-2017-00035
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHBD-W-15-16.5-18
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/28/2016
Device Age2 mo
Event Location Hospital
Date Manufacturer Received01/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/04/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/30/2017 Patient Sequence Number: 1
Treatment
OLYMPUS GIF-Q40 ENDOSCOPE
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