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	06/20/2016
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 guidewire was returned wrapped around itself.Analysis of the returned device revealed that the ptfe (polytetrafluoroethylene) coating was peeled/scraped off at 50.0cm from its proximal tip.The guidewire was also bent and shaped on its distal section.During functional evaluation, there was no resistance encountered during advancement of the guidewire through a demonstration microcatheter.Torquing movement was not smooth due to the bends observed on the guidewire.The cause of the bend on the guidewire contributing to the unsmooth movement during functional evaluation could not be definitively determined as this was not reported.The ptfe coating appeared to be scraped off of the guidewire with the introducer sheath; however, because introducer sheath was not returned with the guidewire and there is no information about an introducer sheath being used during the procedure, the cause of the ptfe peeling cannot be definitely determined.
Event or Problem Description
Analysis of the returned device noted that the polytetrafluoroethylene (ptfe) coating on the guidewire was scraped/ peeling.No consequences to the patient were reported.

• 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: 6051903
• Report Number: 3004859241-2016-00014
• Device Sequence Number: 16150356
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: (01)08714729326250(17)171115(10)18639119
• 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): 06/20/2016

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: 11/15/2017
• Device Catalogue Number: M001468070
• Device Lot Number: 18639119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR