MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40458
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: device was returned for analysis.The device has the polymer tip damaged, its coating was separated from the rest of the body, however, the separated section remained attached to the core wire.The damaged section was located approximately at 299 cm from the proximal end.The core wire was kinked in the same section where the polymer tip was found separated.Dimensional inspection was performed and the middle and proximal od was found within specification.The overall length and od of the distal tip could not be measured due to the device condition.
Event or Problem Description
Reportable based on device analysis completed on 20nov2019.It was reported that tip damage occurred.The target lesion was located in the tibial artery.A 300cm angled tip v-14 control wire guidewire was advanced for treatment.However, during procedure, it was noted that the tip of the wire was frayed.The procedure ws completed with a different device.There were no patient complications nor injuries reported.However returned analysis revealed detached coating.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9412002
• Report Number: 2134265-2019-14849
• Device Sequence Number: 2934532
• Product Code: DQX
• UDI-Device Identifier: 08714729799276
• UDI-Public: 08714729799276
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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 Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0023567710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 66