MAUDE Adverse Event Report: COOK ENDOSCOPY TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

Catalog Number TXR-8.5-12-15-A

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device: common name: gca.Biliary catheter for stone removal that may also allow for irrigation and contrast injection.Product code: gca.Initial reporter occupation: unknown.Investigation evaluation: the customer provided two pictures.In the first picture, the device is seen through the clear side of the pouch.A lot number is not visible.The second picture shows the whole device with the syringe attached.Upon zooming into the distal end it was confirmed there is balloon material missing.All the ends do not match up, and a small portion is missing.The catheter appears to have no damage.The report is considered confirmed based solely on the image provided.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.A split or rupture in the balloon material can occur if the balloon 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." the instructions for use contain the following: ¿warning: do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy¿.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.

Event Description

During a cholecystectomy procedure, the physician used a tri-ex extraction balloon with multiple sizing.During this procedure, the balloon catheter [sic] broke when it was introduced, requiring the removal of the defective material.The material was exchanged, and the surgery was completed without complications.A photo of the device was provided which depicts a syringe attached to the device.There is no identifiable crack or breakage to the catheter.The balloon appears to be missing some mid to lower part of the material [balloon component material detaches or is missing].According to the initial reporter, a section of the device did not remain inside the patient¿s body.However, there is a piece of the balloon material that is missing and the location is unknown.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
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 11021635
• MDR Text Key: 242312518
• Report Number: 1037905-2020-00559
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002268569
• UDI-Public: (01)10827002268569(17)210323(10)W4333393
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2021
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W4333393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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
• Patient Age: 60 YR