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

Catalog Number	M001468070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable.
Event or Problem Description
It was reported that subject device was broken upon removal.The broken part was removed safely from the patient body with the microcatheter as one unit.There were no clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that subject device was broken upon removal.The broken part was removed safely from the patient body with the microcatheter as one unit.There were no clinical consequences to the patient due to this event.
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 received in two fragments and the polytetrafluoroethylene (ptfe) coating was scrapped closed to the fracture site.Magnified examination of the fracture site showed the core wire was fractured and bent at the fracture site.From the condition of the fracture, functional analysis was not being performed due to the anomalies found on the product.Additional information provided by the customer indicated that no anomalies were noted to the guidewire during the initial inspection and preparation, the device was prepared as per the device direction for use (dfu), continuous flush was maintained, the breakage was noticed upon removal from the patient, and the broken part was removed safely from the patient with the microcatheter as one unit.Analysis of the device revealed bending at the fracture site which is an indication of excessive manipulation during use.From the condition of the fracture, it appears that the guidewire kinked and then separated due to handling.Therefore, a probable cause of handling damage has been assigned to the as reported 'guidewire broken' and the as analyzed ' guidewire kinked'.It is possible the ptfe coating was damaged due to insecure tightening of the torque device.However, this could not be definitively assessed since the torque device was not returned for analysis.Therefore, a cause of undeterminable has been assigned to the as analyzed 'nv - guidewire ptfe coating peeling'.

• 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: 8011369
• Report Number: 3008853977-2018-00059
• Device Sequence Number: 1302977
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 12/19/2018

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: 04/11/2020
• Device Catalogue Number: M001468070
• Device Lot Number: 21983610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 10/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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: SL-10 MICROCATHETER (STRYKER)