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

Catalog Number TXR-8.5-12-15-A

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

During an endoscopy procedure, a cook tri-ex extraction balloon with multiple sizing was used.The balloon broke during removal, and a fragment of the device remained in the patient.The detached fragment was left to pass naturally.The detached section of the device was left to pass naturally.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: our evaluation of the returned device confirmed the report.The device was returned and the balloon material, approximately 7 mm long was not attached.The joints of the balloon were still attached to the catheter by the threads and adhesive.The syringe was tested and air would flow out of the port of the balloon.This device has an expiration date of 09/06/2013 and was used on (b)(6) 2014.The device was used greater than 14 months beyond the expiration date.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 conclusions: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The information in this complaint indicates that the device was used on (b)(6) 2014.The expiration date for this lot number is 6-sep-2013.The device was used greater than 14 months beyond the expiration date.Balloon material damage can occur if the balloon has come into contact with a sharp object, such as a sharp stone, or possibly a burr in the endoscope channel or elevator.Balloon damage could lead to subsequent balloon separation.Damage to the balloon material can also occur if added pressure was applied during extraction.The instructions for use direct the user to gently withdraw the inflated balloon toward the papilla and not to asset excessive pressure on the ampulla when extracting stones.The need for sphincterotomy needs to be addressed if the stone does not pass easily.Prior to distribution, all tri-ex 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 tha 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 isolated 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.Additional comments regarding this report: based on the information provided, 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.

• Brand Name: TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4534684
• MDR Text Key: 21777759
• Report Number: 1037905-2015-00035
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K953951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2013
• Device Catalogue Number: TXR-8.5-12-15-A
• Device Lot Number: W3190660
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2014
• Device Age: 26 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2012
• 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 (UNKNOWN TYPE)
• Patient Age: 84 YR