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

Model Number	40458
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and distal tip detachment occurred.The chronic totally occluded (cto) target lesion was located in the highly calcified anterior tibial artery.A 300cm straight tip v-14 control wire was advanced to cross the lesion and a 2x120 coyote balloon catheter was used for support.However, during the procedure, the wire would not advance further and was buckled approximately half way down the tibial artery.The physician felt a little resistance upon pulling the wire back into the catheter and noticed the small black ball just beyond the catheter tip.The device was completely removed and confirmed that the distal 1cm of polymer was stripped off of the wire.No attempt was made to retrieve the small piece of polymer since it was stuck in the middle of a completed occluded artery causing no obstruction.The physician tried crossing the cto again with a.035 non-bsc wire, but was still unsuccessful.They were satisfied with the successful treatment of the superficial femoral artery, so the procedure was completed.There were no patient complications reported.
Event or Problem Description
It was reported that removal difficulties and distal tip detachment occurred.The chronic totally occluded (cto) target lesion was located in the highly calcified anterior tibial artery.A 300cm straight tip v-14 control wire was advanced to cross the lesion and a 2x120 coyote balloon catheter was used for support.However, during the procedure, the wire would not advance further and was buckled approximately half way down the tibial artery.The physician felt a little resistance upon pulling the wire back into the catheter and noticed the small black ball just beyond the catheter tip.The device was completely removed and confirmed that the distal 1cm of polymer was stripped off of the wire.No attempt was made to retrieve the small piece of polymer since it was stuck in the middle of a completed occluded artery causing no obstruction.The physician tried crossing the cto again with a.035 non-bsc wire, but was still unsuccessful.They were satisfied with the successful treatment of the superficial femoral artery, so the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the v-14 control wire was returned for analysis.A section of the polymer jacket was detached and peeled from the tip at the distal section, and it was observed the wire kinked at the tip.No other issues were noted with the device.Microscopic inspection confirmed the polymer jacket was detached and peeled from the tip at the distal section, and it was observed the wire was kinked at the tip.

• 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: 12264553
• Report Number: 2134265-2021-09708
• Device Sequence Number: 4507495
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2022
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0026371172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR