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

Catalog Number FS-QEB-XL-B

Device Problem Deflation Problem (1149)

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

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received at the time of report submission and the investigation is in progress.A follow up emdr will be sent.Gca biliary catheter for stone removal that may also allow for irrigation and contrast injection.

Event Description

During an endoscopic retrograde cholangiopancreatography, the physician used a cook fusion quattro extraction balloon.It was reported [that] the balloon would not deflate at the target site.The balloon ruptured during the user was pulling the inflated balloon out from an endoscope(olympus' model unknown) with force.He replaced it with another device to complete the procedure.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

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.Photos are included from william cook europe of the packaging of the device and the clear pouch it is being returned in (along with other devices from cook endoscopy).Our laboratory evaluation of the product said to be involved confirmed the balloon was ruptured but could not confirm the report of failure to deflate based on the condition of the returned device.The balloon was not able to be test for inflation and deflation due to the condition of the returned device.The device was returned with the syringe attached.During visual examination, it was noted there was a dark orange/red substance on the distal end of the catheter near the balloon.The catheter had a large curve at the distal end near the balloon.The balloon was broken and detached at the proximal end, and had folded over the distal tip of the catheter/balloon.The balloon remained attached at the distal end.The balloon was folded back over into its original place to see if there were any pieces of balloon material missing.Under magnification, it was noted that no balloon material was missing.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: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation, the balloon was ruptured therefore deflation functionality could not be verified.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all fusion quattro extraction balloons 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 unusual occurrence.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: 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: 14946102
• MDR Text Key: 304364350
• Report Number: 1037905-2022-00364
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002319223
• UDI-Public: (01)10827002319223(17)230406(10)W4582735
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Catalogue Number: FS-QEB-XL-B
• Device Lot Number: W4582735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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 - OLYMPUS, UNKNOWN MODEL