MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING; No Match

Model Number	G31537
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2a: common device name: biliary catheter for stone removal that may also allow for irrigation and contrast injection.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.The instructions for use states, "potential complications associated with ercp include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, and cardiac arrhythmia or arrest.Those that can occur during endoscopic balloon extraction include, but are not limited to: stone impaction, localized inflammation, pressure necrosis." prior to distribution, all fusion extraction balloons with multiple sizing are subjected to a visual and functional test to ensure device integrity.The functional test includes an air inflation test to ensure proper balloon function.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.There have been no other reported occurrences similar in nature during the time period reviewed.Therefore, this report represents an isolated occurrence.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an endoscopic stone removal the physician selected a cook fusion extraction balloon with multiple sizing.It was reported [that] the balloon leaked air after inflation and could not inflate.A new three lumen balloon was immediately replaced, and the device was checked for integrity.The wire guide was exchanged again and the stone was removed from the common bile duct.During this period, the patient's sphincter incision bleeding was significant (normally there should be no bleeding), and the patient's oxygen saturation was monitored to decrease to 86%.After anesthesia treatment, the oxygen saturation was restored to 96 [subject of report], taking about 15 minutes to replace the equipment and treat blood oxygen saturation.A section of the device did not remain inside the patient¿s body.The patient experienced bleeding due to this occurrence.According to the initial reporter, the patient's anesthesia and surgery time were prolonged.

• Brand Name: FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING
• Common Device Name: No Match
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 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: 23993484
• Report Number: 1037905-2026-00009
• Device Sequence Number: 10523704
• Product Code: GCA
• UDI-Device Identifier: 00827002315372
• UDI-Public: (01)00827002315372(17)260128(10)W4909055
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K040129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2026
• Device Model Number: G31537
• Device Catalogue Number: FS-8.5-12-15-A
• Device Lot Number: W4909055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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: UNKNOWN ENDOSCOPE MAKE AND MODEL.
• Patient Age: 62 YR
• Patient Sex: Male