MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID; LITHOTRIPTOR, BILIARY MECHANICAL

Catalog Number M00510880

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  malfunction  

Event Description

When doing an endoscopic retrograde cholangiopancreatography (ercp), the technician went to put the device into the scope and it was seen on fluoro that the plastic sheath was frayed.The technician pulled it out and did not go any further.There was no harm to the patient.Manufacturer response for wire guided retrieval basket, trapezoid rx (per site reporter): none yet.

• Brand Name: TRAPEZOID
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5142039
• MDR Text Key: 27990239
• Report Number: 5142039
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/13/2016
• Device Catalogue Number: M00510880
• Device Lot Number: 18297747
• Other Device ID Number: 08714729296393
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO