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

Catalog Number	M001468050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the guidewire broke in half when removed from the microcatheter (competitor device).There was no clinical consequence to the patient as a result of this event.
Event or Problem Description
It was reported the guidewire broke in half when removed from the microcatheter (competitor device).There was no clinical consequence to the patient as a result of this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The guidewire was returned in two fragments with the torque device; the reported event was confirmed.Magnified examination of the fracture site found the core wire was broken and the guidewire was bent at the proximal and distal side of the fracture site and several places along its length.Analysis of the returned device found the guidewire appeared to break due to excessive manipulation, however, information provided by the physician indicated the patient¿s anatomy was not tortuous and no resistance was encountered during advancement or manipulation of the guidewire.Therefore, an assignable cause for this event cannot be determined.

• Brand Name: TRANSEND EX 014
• 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: 7799451
• Report Number: 3008853977-2018-00044
• Device Sequence Number: 2076185
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K934122
• 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): 10/09/2018

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: 01/17/2020
• Device Catalogue Number: M001468050
• Device Lot Number: 21624789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELOCITY .021 MICROCATHETER (PENUMBRA)