MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC (COOK ENDOSCOPY) TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING; CATHETER, BILIARY, SURGICAL

Model Number	G26856
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an ercp (endoscopic retrograde cholangiopancreatography) , the physician used a tri-ex extraction balloon with multiple sizing.It was reported that after testing the device, the balloon is inflated in the bile duct, has no contact with the stone, and when it is removed from the bile duct it is found without part of the latex of the balloon.A section of the device did not remain inside the patient¿s body.The detached portion of the balloon was retrieved with an extractor basket.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: 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.In the information provided in the report, it states the balloon was tested prior to advancement down the endoscope accessory channel and inflated properly.A pinhole, split, or rupture in the balloon can occur if the balloon material has come into contact with a sharp object, such as a sharp stone or possibly a burr in the endoscope channel.A split or rupture in the balloon material can also occur if added pressure was applied during extraction.The instructions for use direct the user to "gently withdraw the inflated balloon toward the papilla." the instructions for use contain the following: ¿warning: do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy.¿ prior to distribution, all tri-ex extraction balloon with multiple sizing are subjected to a visual inspection and functional testing 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Additional Manufacturer Narrative
This correction follow up report is being submitted to cancel the initial report submitted relating to this event.The initial report stated that the balloon was found without part of the latex [detached balloon portion].Cws evaluated device on 14may2025 and it was determined that there was no section of the device missing; all parts matched up.This has not historically caused or contributed to a serious injury or death so this incident no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This follow up emdr is being sent to cancel the initial emdr sent on this event.See h11 for more details.

• Brand Name: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
• Common Device Name: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (COOK ENDOSCOPY); 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 21546162
• Report Number: 1037905-2025-00194
• Device Sequence Number: 7605718
• Product Code: GCA
• UDI-Device Identifier: 00827002268562
• UDI-Public: (01)00827002268562(17)250625(10)W4848602
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K953951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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 Expiration Date: 06/25/2025
• Device Model Number: G26856
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W4848602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 06/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYDROPHILIC GUIDE (BOSTON); OLYMPUS DUODENOSCOPE; OLYMPUS EXTRACTOR BASKET
• Patient Sex: Unknown