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

Catalog Number	M001468070
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device revealed that the guidewire was kinked likely due to handling.The polytetrafluoroethylene (ptfe) coating was found to be slightly scrapped at kinked section at the proximal end of the wire.During functional evaluation, the guidewire was attached to a torque device and one to one torque was checked, and not smooth torquing was experienced due to kinks and bends on the guidewire.The guidewire hydrophilic coating was examined; the coating was present on the guidewire and met visual specifications.No other anomalies were found.Information available indicated that there were no issues observed to the packing prior to unpacking and that the guidewire kinked upon removal from the hoop dispenser.Based on analysis of the device and information available, and assignable cause of handling was assigned to the ptfe peeling observed.
Event or Problem Description
Analysis of the returned device revealed that the guidewire polytetrafluoroethylene (ptfe) coating was scraped.There was no patient involvement.

• Brand Name: TRANSEND EX 014/205 FLOPPY
• 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: 6648628
• Report Number: 3004859241-2017-00015
• Device Sequence Number: 13676241
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: (01)08714729326250(17)180418(10)19160087
• Combination Product (Y/N): N
• PMA/510(K) Number: K944677
• 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): 06/16/2017

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: 04/18/2018
• Device Catalogue Number: M001468070
• Device Lot Number: 19160087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1