MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION QUATTRO EXTRACTION BALLOON

Catalog Number FS-QEB-A

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

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

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

Continued from procode and common name: gca 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 biohazard bag with the 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 for "would not deflate".The condition of the device prohibited a complete evaluation.The staple from the biohazard bag went through the tubing.The balloon inflation lumen was blocked, when air was injected using the returned syringe, the air would not move through the lumen.The device was soaked in hot water to try and loosen any substance blocking the lumen.After further evaluation, a stylet wire and a wire guide were used to clear the lumen, and contrast was found blocking the lumen and y-body.The whole lumen could not be cleared.A stylet wire was used to verify that the lumens did not intersect, and it was confirmed the lumens were molded correctly inside the y-body.The distal end was viewed under magnification and there is some white substance visible inside the balloon, stopcock, and y-body indicative of dried contrast.The most likely root cause for the device being slow to deflate, is due to the balloon being inflated with liquid contrast.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: during the investigation, contrast was found to be blocking the balloon inflation lumen.Using contrast to inflate the balloon is against the ifu.The ifu states the following: "verify balloon integrity prior to use by attaching enclosed pre-measured syringe to stopcock and inflating balloon with air only." use of the incorrect substance for balloon inflation is the most likely root cause for slow to deflate.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 regarding this report: based on the information provided that contrast blocking the balloon inflate lumen was found, 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.

Event Description

In preparation for a procedure, the user selected a cook fusion quattro extraction balloon.It was reported [that] when the balloon was blown up prior to being used , it did not want to deflate.Different syringes were used.Per qe evaluation, device returned with contrast in the balloon, stopcock, and inflation port [use error].This occurred prior to patient contact; there was no impact to the patient.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• 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: 14978657
• MDR Text Key: 301346026
• Report Number: 1037905-2022-00373
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002482255
• UDI-Public: (01)10827002482255(17)230203(10)W4562062
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2023
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W4562062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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