MAUDE Adverse Event Report: COOK ENDOSCOPY BALLOON REPLACEMENT TUBE; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number	PEG-24-BRT-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the picture provided with this report because the product said to be involved were not provided to cook for evaluation.Our evaluation of the photo provided determined that the balloon has ruptured and a piece of the balloon is missing.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 conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.We can advise that leakage of the balloon can occur if the inflation port was inadvertently flushed in lieu of the feed port, causing over inflation.Prior to distribution, all balloon replacement tubes are one-hundred percent (100%) leak tested and all products must pass this inspection.This inspection includes inflating the balloon, checking for symmetry, looking for weak spots and checking for appropriate bond.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.
Event or Problem Description
During an endoscopy procedure, the physician used a cook balloon replacement tube.As reported to customer relations: the patient realized [underwent] a probe exchange and when the doctor inflated the balloon, it had burst.The doctor removed the probe, opened a new probe and restarted the procedure.The problem does not [did not] occur again.From the picture received with the complaint, balloon material looks to be missing.

• Brand Name: BALLOON REPLACEMENT TUBE
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5511243
• Report Number: 1037905-2016-00061
• Device Sequence Number: 10939608
• Product Code: KNT
• UDI-Device Identifier: 00827002226890
• UDI-Public: (01)00827002226890(17)170316(10)W3549846
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K912047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PEG-24-BRT-S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2016
• Device Age: 11 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2016
• Initial Report FDA Received Date: 03/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR