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

Catalog Number	M003468140
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during loading of the guidewire, the interventionalist observed particles when withdrawing the guidewire into the insertion tool.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.Visual inspection of the subject device discovered that the guidewire was returned with the introducer tool, the distal section of which had a loose white substance on it.The ptfe coating was examined under magnification and it was revealed that it was scraped off at the 141 cm from the proximal end.Additionally, the guidewire was bent and stretched on its proximal end, most likely due to handling of the device during the procedure or shipping, but this could not be definitely determined.A functional testing was not performed due to the nature of the reported event.Sem (electron microscopy) and edx spectroscopy test indicated that the particles were likely from the polytetrafluoroethylene (ptfe) guidewire coating, caused by scraping of the coating by the insertion tool during use.Information from complaint indicated that the particles were observed during preparation when withdrawing the guidewire into the introducer tool.Therefore, an operational context was assigned to the event.
Event or Problem Description
It was reported that during loading of the guidewire, the interventionalist observed particles when withdrawing the guidewire into the insertion tool.There was no patient involvement.

• Brand Name: TRANSEND .014 ES 300CM ( 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: 6122435
• Report Number: 3004859241-2016-00016
• Device Sequence Number: 16232748
• Product Code: DQX
• UDI-Device Identifier: 08714729441731
• UDI-Public: (01)08714729441731(17)180328(10)19079407
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 06/12/2017

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: 03/28/2018
• Device Catalogue Number: M003468140
• Device Lot Number: 19079407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1