MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in the popliteal artery.A 150cmx8cm poly tip v-18 control wire was used together with a rubicon support catheter.The wire was used to probe the vessel occlusion.However, upon pulling the wire back into the end of the rubicon, the physician noticed that the coating of the tip of the wire was hanging off.The physician was able to pull the wire and the hanging piece back into the rubicon.The wire was then replaced with a victory wire and the same rubicon was used.There were no patient complications reported and the patient's status was good.
Additional Manufacturer Narrative
Initial reporter zip/post code - (b)(6).Initial reporter phone - (b)(6).Device evaluated by mfr.: the unit returned has the distal tip damaged, as part of overall visual revision.During the product analysis it was noticed that the polymer sleeve twisted from the core wire at the proximal section.Total length of the returned wire was 150 cm and 8.5 cm of polymer was detached.As a part of the analysis, the device was inspected in a high magnification visual system and it was possible to observed that the section of the core wire left exposed has remains of the adhesive, known as thixon, used to bond the polymer sleeve and the core wire.
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in the popliteal artery.A 150cm x 8cm poly tip v-18 control wire was used together with a rubicon support catheter.The wire was used to probe the vessel occlusion.However, upon pulling the wire back into the end of the rubicon, the physician noticed that the coating of the tip of the wire was hanging off.The physician was able to pull the wire and the hanging piece back into the rubicon.The wire was then replaced with a victory wire and the same rubicon was used.There were no patient complications reported and the patient's status was good.

• Brand Name: V-18 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8504120
• Report Number: 2134265-2019-03755
• Device Sequence Number: 16551344
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 01/10/2021
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0023176393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/20/2019
• 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: GUIDE EXTENSION CATHETER: RUBICON; GUIDE EXTENSION CATHETER: RUBICON; GUIDE EXTENSION CATHETER: RUBICON