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	08/01/2018
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 transcend guidewire was returned along with the volcano catheter.The torque device was not returned.Visual examination of the returned device revealed that the guidewire was kinked on its polytetrafluoroethylene (ptfe) section at approximately 27.0cm from its distal end.The guidewire was also bent on its ptfe section at approximately 10.0cm and 80.0cm from its proximal end and on several other places along its length.The ptfe was slightly scrapped on its proximal section.The volcano catheter was bent in the middle section.The information in the event description states that when the catheter was advanced over the guidewire, the guidewire was stuck in the monorail port and the guidewire was removed from the ivus catheter and used in the procedure.It is possible that the force may have been exerted on the guidewire during this step as well as at the time of manipulation during the procedure.Therefore, it is likely that the procedural factors mentioned above may have caused the anomalies found during analysis.Therefore, an assignable cause of procedural factors has been assigned to observed guidewire kink and peeling.
Event or Problem Description
During analysis of the returned product, ot was found that the guidewire polytetrafluoroethylene (ptfe) was peeled/scraped off.There were no 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: 7954606
• Report Number: 3008853977-2018-00057
• Device Sequence Number: 1584984
• 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
• Report Date (Section B): 10/10/2018

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: 01/16/2020
• Device Catalogue Number: M001468080
• Device Lot Number: 21617649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR