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 Material Rupture (1546)

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

Event Date 10/11/2023

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 user] inflated the balloon with the syringe from the package while finding the balloon shrinks immediately before entering the endoscope working channel.User suspected the leaking issue.User then changed to another same device to complete the procedure.There was no reportable information at this time.This device returned with a ruptured balloon.Under magnification we can see that not all sections match up and there is a section of the balloon material missing [subject of report].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 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 report.The device was returned with the syringe still attached to the inflation port.The balloon was examined and it was noted that the balloon was ruptured.Under magnification the balloon rupture shows that there is a section of the balloon material is missing.No other anomalies were detected with the device.The device history record for the lot # said to be involved was reviewed.Nonconformances that could potentially be related to the complaint were contained in the associated dhr.The nonconformance documentation supports the affected device(s) were dispositioned appropriately prior to release of this lot.There is no evidence nonconforming product was released for distribution.In an effort to heighten awareness of the potential connection of the customers report to the current manufacturing processes production personnel were notified.Investigation conclusion: our evaluation of the returned device confirmed the report, the balloon material ruptured.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.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.In the information provided in the report, it states the balloon was tested prior to advancement down the endoscope accessory channel and did not inflate properly.A pinhole, split, or rupture in the balloon can occur if the balloon material has come into contact with a sharp object.Prior to distribution, all fusion extraction balloon with multiple sizing 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: 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): 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: 18685533
• MDR Text Key: 335129177
• Report Number: 1037905-2024-00078
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• PMA/PMN Number: K040129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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: W4727721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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