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

Model Number	M001468070
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device found that the guidewire was kinked and bent, likely due to excessive manipulation.The guidewire was also separated at 112.3cm from its distal end and ptfe (polytetrafluoroethylene) coating was peeled off; the proximal guidewire fragment was not returned.Based on the condition of the fracture site under magnified examination, it is likely the guidewire was bent and kinked first and then separated due to excessive manipulation.Based on the information provided and analysis of the device, the guidewire break was likely due to procedural factors which limited the performance of the device.The observed ptfe coating peeling is consistent with damage from an insecurely tightened torque device, however, because the torque device was not returned for analysis, the cause cannot be determined.An assignable cause of operational context was assigned to this event.
Event or Problem Description
Analysis of the returned device found that the guidewire was broken and the ptfe (polytetrafluoroethylene) coating was peeled off.There was no clinical consequence to the patient as a result of this event.

• 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: 7509100
• Report Number: 3008853977-2018-00024
• Device Sequence Number: 11265523
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: (01)08714729326250(17)190531(10)20592747
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Report Date (Section B): 05/11/2018

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: 05/02/2019
• Device Model Number: M001468070
• Device Catalogue Number: M001468070
• Device Lot Number: 20592747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR