MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-XL-B

Device Problems Deflation Problem (1149); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

In preparation for a procedure, the user selected a cook fusion quattro extraction balloon.It was reported [that the balloon] was difficult to deflate (deflate slowly), so considering safety, it was discontinued to use and changed to another same device (unknown lot).This occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an clear plastic bag with an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the device confirmed the report based on the condition of the returned device, there was contrast present throughout the catheter and balloon.The balloon was returned in the coiled position with the syringe still attached to the inflation port.There was contrast noted on the distal end of the catheter and balloon during a visual examination.The balloon was soaked in warm water to attempt to remove the contrast and test for inflation.During our functional test the balloon was submerged in water and the syringe provided was used to inflate the balloon with air.During attempting to inflate the balloon with air, the balloon would not inflate at all and there was resistance in the syringe when trying to inflate.Under visual magnification, it could be seen that there was contrast inside of the balloon, in the inflation catheter port, and throughout the catheter.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 returned device confirmed the report based on the condition of the returned device; there was contrast present inside the balloon, port, and catheter which suggests the balloon was not inflated with air.The instructions for use (ifu) states: "verify balloon integrity prior to use by attaching enclosed pre-measured syringe to stop cock and inflating balloon with air only." this is the most likely cause for the user's complaint of balloon being unable to deflate and or not being able to inflate the balloon.Prior to distribution, all fusion quattro extraction balloon are subjected to a visual inspection and functional testing to ensure device integrity.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.Additional comments: based on the evaluation of the returned device that there was contrast present throughout the catheter and balloon, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• 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: 18959223
• MDR Text Key: 339157497
• Report Number: 1037905-2024-00175
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002319223
• UDI-Public: (01)10827002319223(17)241004(10)W4770990
• Combination Product (y/n): N
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-QEB-XL-B
• Device Lot Number: W4770990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2023
• 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: UNKNOWN ENDOSCOPE