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

Model Number	81735
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wire peeling occurred.A 135cm transend guide wire was selected for use for a transarterial chemoembolization procedure.During preparation, the distal tip coating was found peeling when it was shaped 3 to 4 times.The procedure was completed with another of the same device and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch.The returned guidewire showed a kinked section located approximately at 132.5 cm from the proximal end.The coating of the distal tip was carefully inspected and no damages were observed.No more damages were found in the returned device.Outer diameter of the distal tip, middle and proximal section of the device were within specification.
Event or Problem Description
It was reported that wire peeling occurred.A 135cm transend guide wire was selected for use for a transarterial chemoembolization procedure.During preparation, the distal tip coating was found peeling when it was shaped 3 to 4 times.The procedure was completed with another of the same device and no patient complications were reported.

• 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: 9985887
• Report Number: 2134265-2020-05390
• Device Sequence Number: 17068871
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 10/29/2021
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0024684369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR