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

Catalog Number	M001468080
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that while the guidewire was pushed through the microcatheter, the hydrophilic coating was peeled off.There were no consequences to the patient.
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 and along with the excelsior sl-10 microcatheter used.Analysis of the returned device revealed that there were no anomalies noted to the ptfe (polytetrafluoroethylene) and hydrophilic coating.The guidewire was not shaped on its distal section.The guidewire was introduced and advanced through the excelsior sl -10 catheter proximal end during functional evaluation.There was resistance encountered during advancement of the guidewire through the microcatheter.Information available indicated that no anomalies were noted to the guidewire prior to use and no anomalies were noted to the coating on the guidewire during device analysis.The reported peeling of the guidewire coating could not be confirmed during analysis.Therefore, an assignable cause of "not confirmed" has been assigned to this investigation.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that while the guidewire was pushed through the microcatheter, the hydrophilic coating was peeled off.There were no consequences 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: 5913903
• Report Number: 3004859241-2016-00011
• Device Sequence Number: 26000
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: (01)08714729326267(17)171106(10)18605889
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K931584
• 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,Followup
• 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: 07/12/2017
• Device Catalogue Number: M001468080
• Device Lot Number: 18712563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2016
• Supplement 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
• Patient Age: 56 YR