MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND .014 FLOPPY 300 CM ( IC 300 ); WIRE, GUIDE, CATHETER

Catalog Number	M003468150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during shaping of the guidewire tip, the tip broke.There was no patient involvement.
Event or Problem Description
It was reported that during shaping of the guidewire tip, the tip broke.There was no patient involvement.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The guidewire was examined and it was discovered that the guidewire was slightly bent at 3.0cm from its distal end.The guidewire was also slightly bent along its length.The guidewire platinum coil was examined and found to be within specifications.The guidewire was examined along its length and no other anomalies were observed.The guidewire outer diameter was checked and found to be within specifications.The guidewire ptfe coating was examined under magnification and no anomalies were observed with the polytetrafluoroethylene (ptfe) coating.During functional evaluation the guidewire torque was not smooth due to the bend on the guidewire.The cause for the observed bends and unsmooth torque and the relation to the reported and unconfirmed break issue could not be definitively determined because these were not initially reported.However, the guidewire distal end was intact (no break); 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 during shaping of the guidewire tip, the tip broke.There was no patient involvement.

• Brand Name: TRANSEND .014 FLOPPY 300 CM ( IC 300 )
• 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: 5676496
• Report Number: 3004859241-2016-00003
• Device Sequence Number: 16194920
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: (01)08714729441748(17)170716(10)18209343
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K022357
• 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,Followup
• Report Date (Section B): 04/29/2016

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: 07/16/2017
• Device Catalogue Number: M003468150
• Device Lot Number: 18209343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/06/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/24/2016
• Supplement Report FDA Received Date: 06/20/2016; 08/01/2016
• 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
• Patient Weight: 61