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

Catalog Number	M001468070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the procedure, the distal tip of the guidewire (subject device) had separated when advanced into the microcatheter against frictions.The guidewire and the microcatheter were retrieved together as one unit without any clinical consequences for the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specification.A review of the manufacturing records was performed and no issues that could have contributed to this event were found.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Based on the information currently available; the cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that during the procedure, the distal tip of the guidewire (subject device) had separated when advanced into the microcatheter against frictions.The guidewire and the microcatheter were retrieved together as one unit without any clinical consequences for the patient.

• 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: 5785308
• Report Number: 3004859241-2016-00005
• Device Sequence Number: 341363
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: (01)08714729326250(17)170726(10)18236418
• 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,Followup
• Report Date (Section B): 06/14/2016

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: 07/26/2017
• Device Catalogue Number: M001468070
• Device Lot Number: 18236418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2016
• Supplement Report FDA Received Date: 09/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1