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

Catalog Number	M001468080
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the polytetrafluoroethylene (ptfe) coating of the subject guidewire was observed to be peeling.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and there were no anomalies noted to the polytetrafluoroethylene (ptfe) coating.The guidewire hydrophilic coating was examined and the coating is present on the guidewire and meets visual specifications.Functional testing revealed that the guidewire dimensions were determined to be within specification.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event was not confirmed as the coating met specifications, therefore a cause of not confirmed will be assigned to the investigation.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during preparation, the polytetrafluoroethylene (ptfe) coating of the subject guidewire was observed to be peeling.There were no reported clinical consequences to the patient.

• 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: 8749144
• Report Number: 3008853977-2019-00054
• Device Sequence Number: 11362304
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: 08714729326267
• Combination Product (Y/N): N
• 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): 08/30/2019

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: 07/05/2020
• Device Catalogue Number: M001468080
• Device Lot Number: 22343426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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: GUIDEWIRE (STRYKER); GUIDING CATHETER (ASAHI); MICROCATHETER (CORDIS); GUIDEWIRE (STRYKER); GUIDING CATHETER (ASAHI); MICROCATHETER (CORDIS)
• Patient Age: 70 YR