MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 014/205 PLATINUM; WIRE, GUIDE, CATHETER

Catalog Number	M001468080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Inspection of the returned device found it was stretched and kinked, likely due to procedural factors, and broken at distal tip.Magnified examination of the fracture site and analysis of scanning electron microscopy (sem) images to further characterize the fracture showed the guidewire was likely bent and pulled, subsequently resulting in the break.The location of the bends and fracture suggest the guidewire was damaged and broke during the procedure, however, an exact cause cannot be determined.
Event or Problem Description
Analysis of the returned guidewire found it was broken at the distal end.There was no clinical consequence to the patient.

• Brand Name: TRANSEND EX 014/205 PLATINUM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• MDR Report Key: 7708743
• Report Number: 3008853977-2018-00031
• Device Sequence Number: 904095
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: 08714729326267
• Combination Product (Y/N): N
• PMA/510(K) Number: K971254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 09/18/2019
• Device Catalogue Number: M001468080
• Device Lot Number: 21150650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1