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

Model Number	40456
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred and was snared to remove the broken piece.The target location was located in the tibial artery.A v-14 control wire was selected and advance though a non-boston scientific catheter.When the wire was pulled back across some plaque, the tip sheared off.The broken piece was retrieved with a snare.The procedure was completed with another wire.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.It was observed that the tip of the guidewire was detached and peeled, moreover the guidewire was bent.Based on analysis of the returned product, the reported allegation of tip detachment was confirmed due to the distal tip condition.
Event or Problem Description
It was reported that tip detachment occurred and was snared to remove the broken piece.The target location was located in the tibial artery.A v-14 control wire was selected and advance though a non-boston scientific catheter.When the wire was pulled back across some plaque, the tip sheared off.The broken piece was retrieved with a snare.The procedure was completed with another wire.No complications were reported, and the patient was stable.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19832715
• Report Number: 2124215-2024-45691
• Device Sequence Number: 20870697
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: 08714729799221
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 02/15/2026
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0033442921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown