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

Model Number	G31537
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued: d2a common device name: biliary catheter for stone removal that may also allow for irrigation and contrast injection.E1 - address 2: (b)(6).Investigation evaluation: a product evaluation was performed only by the photos and video provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos and video provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements, video, and photos describing the event.The first and fourth photos show the distal end of the device and the balloon is socked over the distal tip.The second photo shows an endoscopic image and the balloon is inflated inside the patient.The third photo shows the pouch and the lot number matches the report.The video provided shows the balloon inflated, one can tell they are trying to deflate the balloon, but the balloon remains inflated.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 photos and video provided confirmed the report, however, 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 information provided states the balloon was inflated prior to use and inflated properly.This means the balloon was intact and functioning prior to advancement down the endoscope accessory channel.The instructions for use (ifu) states, "once the balloon is endoscopically visualized in the duodenum, turn the stopcock to the open position and deflate the balloon." prior to distribution, all fusion extraction balloon 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.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 retrograde cholangiopancreatography procedure, the physician was using a cook fusion extraction balloon with multiple sizing.It was reported that the balloon inflated.However, while attempting to expel the air, the balloon remained inflated.As such, the device was replaced with another 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
Continued: d2a common device name: biliary catheter for stone removal that may also allow for irrigation and contrast injection.Investigation evaluation: the product said to be involved was returned in a clear plastic bag with an open pouch from the lot number provided in the report.The label matches the product returned.Photos and a video were provided and reviewed.The first and fourth photos show the distal end of the device, and the balloon is socked over the distal tip.The second photo shows an endoscopic image, and the balloon is inflated inside the patient.The third photo shows the pouch, and the lot number matches the report.The video provided shows the balloon inflated, one can tell they are trying to deflate the balloon, but the balloon remains inflated.Our laboratory evaluation of the product said to be involved confirmed the balloon was ruptured but could not confirm the report of failure to deflate based on the condition of the returned device.The balloon was not able to be tested for inflation and deflation due to the condition of the returned device.The device was returned with the syringe attached directly to the inflation port and the stopcock was returned loose in the pouch.The balloon was broken and the proximal end had folded over the distal end of the catheter.The balloon remained attached at the distal end.The balloon was folded back over into its original place to determine if there were any pieces of balloon material missing.Under magnification, it was noted that no balloon material was 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 conclusion: our evaluation of the photos and video provided confirmed the report.Our evaluation of the returned device found the balloon was ruptured.A definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation; the balloon was ruptured, and therefore deflation functionality could not be verified.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.The information provided states the balloon was inflated prior to use and inflated properly.This means the balloon was intact and functioning prior to advancement down the endoscope accessory channel.The instructions for use (ifu) states, "once the balloon is endoscopically visualized in the duodenum, turn the stopcock to the open position and deflate the balloon." prior to distribution, all fusion extraction balloon 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.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• 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: 23585628
• Report Number: 1037905-2025-00782
• Device Sequence Number: 15863254
• Product Code: GCA
• UDI-Device Identifier: 00827002315372
• UDI-Public: (01)00827002315372(17)260508(10)W4937348
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K040129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 05/08/2026
• Device Model Number: G31537
• Device Catalogue Number: FS-8.5-12-15-A
• Device Lot Number: W4937348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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: SCOPE, UNKNOWN MAKE AND MODEL.
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 72 KG