MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number TXR-8.5-12-15-A

Device Problem Deflation Problem (1149)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.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 with the syringe still attached to the inflation port.A functional test was performed on the balloon; when the balloon was filled with air, no leaks were present in the balloon material.Once the balloon was inflated, pressure was released from the syringe and the balloon deflated within a few seconds (reference attached inflation/deflation video).The device was visually inspected and appeared to be free of bends and kinks along the catheter of the device.The device was measured from the hub to the distal end and measured in the specified tolerance.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 laboratory evaluation of the device could not confirm the complaint, 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 indicates the balloon was inflated prior to use and inflated properly.This means the balloon was intact and functioning prior to advancement through the endoscope accessory channel.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 and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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.

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook tri-ex extraction balloon with multiple sizing.It was reported [that] the balloon would not deflate as it should.The procedure was completed with this device, however it had to be manually deflated.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.

• Brand Name: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
• Type of Device: GCA, CATHETER, BILIARY, SURGICAL
• 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: 18049303
• MDR Text Key: 327260541
• Report Number: 1037905-2023-00529
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002268569
• UDI-Public: (01)10827002268569(17)240922(10)W4767540
• 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: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W4767540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2023
• 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 - OLYMPUS 190