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

Catalog 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	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The microcatheter and torque device used with the guidewire was not returned.Visual inspection revealed that the guidewire was received in two fragments.The proximal fragment was measured to be approximately 86.0cm in length and the distal fragment was approximately 118.0cm in length.The core wire was noted to fractured under magnification.The guidewire was kinked and also bent at 52.0cm and 54.0cm from its proximal end.The guidewire appeared to be was separated due to excessive kinking from the condition of the fracture site.There were no anomalies observed to the hydrophilic coating.The ptfe (polytetrafluoroethylene) coating was scraped off at approximately just proximal and distal to the fracture site and near the observed bends.Functional testing could not be performed due to the condition of the returned device.Information available indicates that the device was prepared as per the dfu, no anomalies were noted after unpacking, and dispenser hoop was flushed with saline before removing the guidewire.During dhr (device history review) review of the product, it was noted that the device expired on 16-june-2017 and the procedure was carried out on the (b)(6) 2018.The physician noted the reported issue of guidewire kink prior to the procedure and completed the procedure successfully with another guidewire.The bending and fracture on the guidewire appeared to be due to excessive manipulation and handling of the guidewire during the procedure.Based on the investigation, it appears that the reported and observed issues occurred from handling damage.
Event or Problem Description
Analysis of the returned device noted that the polytetrafluoroethylene (ptfe) coating on the guidewire was scraped/ peeling and the guidewire was broken.No consequences to the patient were reported.

• 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: 7676300
• Report Number: 3008853977-2018-00030
• Device Sequence Number: 13847459
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

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: 06/16/2017
• Device Catalogue Number: M001468070
• Device Lot Number: 18106379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1