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

Model Number	G48225
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
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.Investigation evaluation: a product evaluation was performed only by the photo provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo 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 and the photo describing the event.The photo shows the device, and the syringe is attached to the inflation port, and the balloon is inflated.It can be noted that the balloon is still inflated and outside of the patient, thus confirming the complaint.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 photo 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 balloon is endoscopically visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all fusion quattro extraction balloons 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 used a cook fusion quattro extraction balloon.It was reported that the balloon failed to deflate, so [physician] used force to pull it out and changed to competitor brand balloon to complete 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.No lot number was returned with the device.A photo was provided and reviewed.The photo shows the device, and the syringe is attached to the inflation port, the stop cock is open to allow deflation and the balloon is inflated.It can be noted that the balloon is still inflated and outside of the patient, thus confirming the complaint.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The balloon inflated and deflated without difficulty.The device was returned in a coiled position with the syringe still attached to the inflation port.The balloon was inflated with air using the syringe provided.The balloon inflated as expected and the stop cock was turned to closed.A visual examination of the balloon did not find any leaks or defects.Upon turning the stopcock to open, the balloon deflated within a few seconds (reference attached deflation video).No other anomalies were detected with the device.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 photo provided confirmed the report, however, our laboratory evaluation of the returned device could not confirm the report, the balloon inflated and deflated without difficulty.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.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 balloon is endoscopically visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all fusion quattro extraction balloons 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 QUATTRO EXTRACTION BALLOON
• 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: 23871946
• Report Number: 1037905-2025-00857
• Device Sequence Number: 11916898
• Product Code: GCA
• UDI-Device Identifier: 00827002482258
• UDI-Public: (01)00827002482258(17)260708(10)W4953862
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K200247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 07/08/2026
• Device Model Number: G48225
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W4953862
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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: UNKNOWN ENDOSCOPE MAKE AND MODEL.
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 56 KG