MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSEND; WIRE, GUIDE, CATHETER

Model Number	81735
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that peeling coating occurred.The target lesion was located in the liver.A 135cm transcend guidewire was advanced.However, during the procedure, the physician tried to make the shape of the distal tip for 3-4 times, and noted peeling coating of the distal tip.The procedure was completed with same device.No patient complications nor injuries reported.The patient was stable.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9861071
• Report Number: 2134265-2020-03649
• Device Sequence Number: 11481809
• Product Code: DQX
• UDI-Device Identifier: 08714729326274
• UDI-Public: 08714729326274
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K941710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0024599335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1