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

Catalog Number HBD-W-18-19-20

Device Problems Crack (1135); Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The condition of the returned device prevented a functional test.A visual examination of the returned device showed that the balloon measured 5.5 cm.The balloon tip had detached from the distal end and was not included in the return of the device.A crack was observed in the catheter approximately 23.5 cm from the proximal end.A kink was observed in the catheter approximately 120 cm from the distal end.A visual examination of the stylet wire showed a kink approximately 118 cm from the distal end of the stylet wire.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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: in the additional information provided, the user indicated that negative pressure and lubrication were not applied to the balloon prior to advancement through the endoscope.This is the most likely cause of balloon material failure.The instructions for use direct the user: "to facilitate passage through the endoscope, apply negative pressure to the device." "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." 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.The application of lubrication will aid in endoscopic advancement and balloon preservation.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: 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 information regarding this report: based on the information provided that lubrication nor negative pressure were applied to the balloon, 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 a dilation procedure, the physician used a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic.The inner catheter broke while inflating the balloon.The following was received on (b)(6) 2017: the catheter was damaged at the patient end.The device was evaluated on 09/06/2017.The returned device was missing the balloon tip.It had detached from the distal end and was not included in the return of the device.A crack was also observed in the catheter approximately 23.5 cm from the patient end.Information was received from the customer on 09/12/2017 regarding the location of the detached balloon material: ¿we inserted the balloon into the endoscope.When it came out inside the patient [exited the endoscope channel], the balloon had a defect.We did not see any part detaching from the balloon.So if a part of the balloon is missing or has detached, we cannot state if the material detached before, during or after the procedure.In case of detachment inside the patient, it probably stayed there because we did not retrieve anything.¿.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Type of Device: KNQ, 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 Key: 6858888
• MDR Text Key: 86160084
• Report Number: 1037905-2017-00563
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002517981
• UDI-Public: (01)00827002517981(17)200613(10)W3877801
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-18-19-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2017
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1