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	10/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the guidewire had broken during use.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that the guidewire had broken during use.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date: added.H3 device evaluated by mfg: updated.H3 summary attached: updated.D4 expiration date: added.D10 product available to stryker: updated.D10 returned to manufacturer on: updated.The device history record review confirms that the device met all material, assembly and performance specifications.The microcatheter used with the guidewire was not returned.The torque device was returned.Magnified inspection revealed that the guidewire was received in two fragments and that the core wire was fractured.The guidewire was kinked at the fracture site as well.From the condition of the guidewire at the fracture site, it appears that the guidewire separated due to excessive bending, kinking and excessive torque.The guidewire was found to be bent proximal to the separated site and kinked on several places along its ptfe (polytetrafluoroethylene) length.No anomalies were observed with the hydrophilic and ptfe coating.Functional testing could not be performed due to the damaged condition of the returned guidewire.Information available indicated that the device was confirmed to be in good condition prior to use,no friction was encountered during the procedure and the guidewire moved freely within the catheter.It was also reported that continuous flush was not maintained and the device had already been used once, re-hooped and when it was being reintroduced into the catheter, the guidewire was noted to have snapped midway through re-introduction.Based on analysis, it appeared that the guidewire may have gone through excessive manipulation during the procedure.It is also possible that since continuous flush was not used, the guidewire may have lost its lubricity and during re-hooping and reintroduction of the guidewire into catheter, excessive manipulation may have caused the guidewire to break.Therefore based on all of the information available, an assignable cause of handling damage was assigned to the observed and reported damages.

• 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: 8120973
• Report Number: 3008853977-2018-00069
• Device Sequence Number: 13519172
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: 08714729326267
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K971254
• 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): 01/03/2019

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: 11/30/2019
• Device Catalogue Number: M001468080
• Device Lot Number: 21452696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: MICROCATHETER (UNKNOWN MANUFACTURER)