MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING; BILIARY CATHETER FOR STONE REMOVAL; ALSO FOR IRRIGATION AND CONTRAST INJECTION

Model Number	G26856
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an common bile duct stone removal, the physician used a cook tri-ex extraction balloon with multiple sizing.The user opened the package and pre-tested the balloon by inflating it with air, but found out there was difficulty deflating the balloon.The user changed to a new one to continue the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white plastic bag with an open pouch from the lot number provided in the report.The label matches the product returned.The photo provided shows the pouch and the lot number matches that in the report.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the syringe still attached to the inflation port.The device returned with clear liquid drops inside of the syringe; this substance is assumed to be water or saline.During a function test, the device was inflated with air from the returned syringe and the balloon inflated as expected, and the stop cock was turned to closed.Upon turning the stopcock to open, the balloon took longer than expected to deflate, however the balloon fully deflated.A visual examination of the balloon and catheter did not reveal any defects.Under visual magnification, dried clear liquid spots could be seen inside the balloon.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: our evaluation of the returned device confirmed the report for difficult balloon deflation.The balloon and syringe were found to contain a clear liquid substance in the syringe and dried liquid spots inside of the balloon.Using water or saline to inflate the balloon is against the ifu.The ifu states the following: "verify balloon integrity prior to use by attaching enclosed pre-measured syringe to stopcock and inflating balloon with air only." use of the incorrect substance for balloon inflation is the most likely root cause for the balloon being difficult to deflate.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 comments: based on the presence of liquid in the syringe and inside 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.

• Brand Name: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
• Common Device Name: BILIARY CATHETER FOR STONE REMOVAL; ALSO FOR IRRIGATION AND CONTRAST INJECTION
• 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: 22053765
• Report Number: 1037905-2025-00393
• Device Sequence Number: 12735779
• Product Code: GCA
• UDI-Device Identifier: 00827002268562
• UDI-Public: (01)00827002268562(17)250910(10)W4868968
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Report Date (Section B): 05/20/2025

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: 09/10/2025
• Device Model Number: G26856
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W4868968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS TJF-240
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG