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

Catalog Number FS-8.5-12-15-A

Device Problem Deflation Problem (1149)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

In preparation for a procedure, the user selected a cook fusion extraction balloon with multiple sizing.It was reported [that] the extraction balloon inflates but it remains blocked; it does not deflate.This occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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.Prior to distribution, all fusion extraction balloon 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 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.

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.Our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The balloon inflated and deflated without difficulty.The device was returned without the syringe and stopcock.A functional test was performed on the balloon using a syringe and stopcock from our stock; when the balloon was filled with air, no leaks were present in the balloon material.Once the balloon was inflated, pressure was released from the syringe and the balloon deflated within a few seconds (reference attached inflation/deflation video).The device was visually inspected and appeared to be free of bends and kinks along the catheter of the device.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 device could not confirm the complaint, the balloon inflated and deflated without difficulty.A definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting as the syringe and stopcock were not returned.This limits our ability to conclusively determine a cause.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 extraction balloon 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 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 EXTRACTION BALLOON WITH MULTIPLE SIZING
• 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): WILSON COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 8002454707
• MDR Report Key: 18921928
• MDR Text Key: 337877816
• Report Number: 1037905-2024-00161
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002315379
• UDI-Public: (01)10827002315379(17)241108(10)W4782210
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-8.5-12-15-A
• Device Lot Number: W4782210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• 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