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

Catalog Number HBD-W-15-16.5-18-J

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturer exemption number: (b)(4).This mdr report is part of the 227 pilot program.For the one (1) reported event, the device was returned to cook endoscopy.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The product said to be involved was returned with the wire guide and wire flow switch off of the proximal end of the device.The balloon was returned in a un-fluted state.During a functional test, the balloon was inflated using a 60cc syringe and an inflation handle.The balloon was inflated to each pressure gradually until reaching the maximum 6 atm.No leakages were found.The catheter was put in multiple stressed positions to see if any leakage was occurring in the catheter, but no leaks were observed.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.A definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A possible contributing factor to balloon material 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.Another possible contributing factor to balloon material damage is failure to apply negative pressure to the balloon dilator prior to advancement through the endoscope.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.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 wire guided balloon esophageal-pyloric-colonic are subjected to a visual examination to ensure device integrity.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.

Event Description

This report summarizes one (1) malfunction event.A review of the event indicated that during an esophageal dilation procedure, the physician used a cook hercules 3 stage wire guided balloon esophageal-pyloric-colonic.When inflating the balloon, the user confirmed that contrast media was leaking from the tip.Then, another device was used instead to complete the procedure.The one (1) event involved a patient with no consequences.

• 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: 5828996
• MDR Text Key: 50635770
• Report Number: 1037905-2016-00209
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002319820
• UDI-Public: (01)00827002319820(17)170604(10)W3436121
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HBD-W-15-16.5-18-J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2016
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• 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
• Treatment: OLYMPUS ENDOSCOPE (UNKNOWN MODEL)