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

Catalog Number	M001468050
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The transend ex guidewire was returned in two fragments.Visual and microscopic inspection of the device found that the guidewire was bent on several places along its length and was fractured.The guidewire ptfe coating was examined and it was found to be scrapped off very close to the fracture site and at approximately 17.0cm from its proximal end.The guidewire outer diameter and length specifications were found within specifications.Per the device directions for use (dfu): "excessive tightening of the torque device onto the wire may result in abrasion of the coating of the wire." it is likely that the ptfe scraping appeared to be related to a deviation from the dfu.It was reported that resistance was felt when the guidewire was advanced in the middle of the renegade microcatheter.It is probable that the resistance caused the guidewire to bend, fracture, and the ptfe around the fracture site to peel.However, the cause of the resistance is could not be determined.
Event or Problem Description
Analysis of the returned device noted that the guidewire was broken and the guidewire polytetrafluoroethylene (ptfe) coating was peeling.No consequences to the patient were reported.

• Brand Name: TRANSEND EX 014
• 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: 6188901
• Report Number: 3004859241-2016-00019
• Device Sequence Number: 866135
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: (01)08714729187332(17)180114(10)18811035
• Combination Product (Y/N): N
• PMA/510(K) Number: K934122
• 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): 12/20/2016

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: 01/14/2018
• Device Catalogue Number: M001468050
• Device Lot Number: 18811035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RENEGADE MICROCATHETER (STRYKER)