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

Catalog Number	M001468050
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that when the guidewire was being prepped for the procedure, the hydrophilic coating was observed to be peeling from the tip.The physician replaced it with a new guidewire and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The torque device used with the guidewire was returned.Visual inspection of the device revealed that the polymer sleeve was not smooth on its proximal end, proximal end was not melted down on the core wire and not tight on the core wire.Approximately 1.5cm polymer sleeve piece was overerlapping and hanging loose on the polymer middle section at approximately 17.0cm from the guidewire distal end.No anomalies were observed with the ptfe(polytetrafluoroethylene) coating and hydrophilic coating.The guidewire was also slightly bent along its length.Functional testing could not be performed due to the nature of the complaint and the hydrophilic coating was observed to be present on the guidewire.The anomalies noted for the polymer sleeve were determined to be potential manufacturing defect which likely contributed to the reported event and damages observed during analysis.Therefore, an assignable cause of manufacturing was assigned to this event.Based on the information available and analysis results, the reported event of hydrophilic coating peeling was not confirmed and the manufacturer continues to investigate the matter.
Event or Problem Description
It was reported that when the guidewire was being prepped for the procedure, the hydrophilic coating was observed to be peeling from the tip.The physician replaced it with a new guidewire and continued the procedure without clinical consequences to the patient.

• 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: 7813925
• Report Number: 3008853977-2018-00046
• Device Sequence Number: 11128652
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• 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): 11/02/2018

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: 06/12/2019
• Device Catalogue Number: M001468050
• Device Lot Number: 20876386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1