MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

Catalog Number TXR-8.5-12-15-A

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook tri-ex extraction balloon with multiple sizing.It was reported [that] the extraction balloon ruptured [per photo provided, balloon component material appears to be missing] during an attempt to remove the gallstone.The client informed that, during the visual inspection, he did not observe any abnormality, he tested the balloon before passing it through the device with its own syringe filled with air and the catheter to attempt to remove the stone.The client also reports that he underwent a sphincterotomy prior to the passage of the balloon.It was reported that 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.

Manufacturer Narrative

Continued: common device name: gca biliary catheter for stone removal that may also allow for irrigation and contrast injection.Product code: gca.Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.The photo shows the distal end of the device, where the balloon material is ruptured.From the photo, it appears that the balloon material edges do not match up and a portion appears to be missing.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos and statements describing the event.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." prior to distribution, all tri-ex 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): 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: 16254483
• MDR Text Key: 308453428
• Report Number: 1037905-2023-00034
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002268569
• UDI-Public: (01)10827002268569(17)230818(10)W4628663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W4628663
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - UNKNOWN MAKE AND MODEL
• Patient Age: 61 YR
• Patient Sex: Female