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

Catalog Number	M001468070
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire (subject device)proximal part was found broken during unpacking.There were no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was returned.It was revealed that the guidewire was kinked/bent first and then fractured, the ptfe (polytetrafluoroethylene) coating was scraped/peeled near fracture site.Functional analysis could not be performed due to the anomalies found on the product.Based on the information available and analysis of the device, it appears that the anomalies occurred because of handling during unpacking of the device.
Event or Problem Description
It was reported that the guidewire (subject device) proximal part was found broken during unpacking.There were no reported clinical consequences to the patient due to this event.

• 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: 6239406
• Report Number: 3004859241-2017-00002
• Device Sequence Number: 16321205
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 8714729326250
• 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: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2017

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: 04/21/2017
• Device Catalogue Number: M001468070
• Device Lot Number: 17916172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1