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

Catalog Number	M001468080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during a procedure the guidewire broke outside the patient.No consequences to the patient were reported.No further information is available.
Additional Manufacturer Narrative
Correction: product available to stryker - corrected.The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection of the returned device found that the guidewire was received in two fragments: the proximal fragment was measured to be 82.3cm in length and the distal fragment was 121.5cm in length.Magnified examination of the fracture site showed the core wire was fractured.The guidewire was bent at the fractures site.From the condition of the guidewire at the fracture site, it appears that the guidewire was bent first and then separated.The guidewire was bent just proximal to the fracture site and on its distal section.The guidewire polytetrafluoroethylene (ptfe) coating was scrapped off very close to the fracture site.The guidewire hydrophilic coating was present on the guidewire and met visual specifications.The bending and fracture on the guidewire appeared to be due to excessive manipulation.Analysis of the device found that the device was bent along the length and close to the fracture site.The bending, fracture, and ptfe scraping appeared to be caused by excessive manipulation.Examination of the separation site showed that the guidewire was bent first and then separated, suggesting the separation occurred from bending overload.Because the reported and analyzed issues appeared to occur from handling without direct patient contact during the procedure, a probable assignable cause of handling damage was assigned.
Event or Problem Description
It was reported that during a procedure the guidewire broke outside the patient.No consequences to the patient were reported.No further information is available.

• 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: 5853949
• Report Number: 3004859241-2016-00008
• Device Sequence Number: 13759958
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: (01)08714729326267(17)171123(10)18669896
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K971254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2016

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: 11/23/2017
• Device Catalogue Number: M001468080
• Device Lot Number: 18669896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2016
• Supplement Report FDA Received Date: 10/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1