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 01/27/2023

Event Type  malfunction  

Event Description

During an endoscopic procedure for removal of common bile duct stones, the physician used a cook fusion quattro extraction balloon.It was reported [that] the balloon did not deflate in the bile duct.He said that the user burst the balloon to retrieve it, however the exact timing was unknown, and no balloon fragments had been left behind in the patient's body.The procedure was completed by using another product 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

Information regarding suspect medical device section common device name: biliary catheter for stone removal that may also allow for irrigation and contrast injection procode: gca.Investigation evaluation: the product said to be involved was returned in a clear biohazard bag with 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 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 tested for inflation and deflation due to the condition of the returned device.In the report it states the balloon was broken while trying to pull it out of the endoscope because the balloon would not deflate as expected.The balloon was returned with the provided syringe still attached and the device in the coiled position.The catheter had a large curve at the distal end near the balloon.The balloon was broken and the proximal end 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 investigation did not identify a cause of the balloon to not deflate.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 evaluation of the returned device confirmed the report, the balloon material was ruptured due to it being unable to deflate.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.The instructions for use (ifu) states, "once balloon is endoscopically visualized in duodenum, turn stopcock to open position and deflate balloon." prior to distribution, all fusion quattro extraction balloon 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.

• 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: 16407607
• MDR Text Key: 309952139
• Report Number: 1037905-2023-00078
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002319223
• UDI-Public: (01)10827002319223(17)231201(10)W4661101
• 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
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: FS-QEB-XL-B
• Device Lot Number: W4661101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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