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

Model Number	H74939216730020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred, and portion of the device fragment remained inside the patient.The target lesion was located in the non-tortuous and heavily calcified left anterior tibial artery.A v-14 control wire was selected for used.During procedure, the v-14 control wire was advanced along with a non-boston scientific catheter.It was noted that when the v-14 control wire was pulled back, the tip broke off in the patient.Part of the wire was unable to be retrieved and remained inside the patient.A second v-14 wire was advanced with non-boston scientific catheter and there was no issue.The procedure was not completed due to this event.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the v-14 control wire was returned for analysis.A visual examination identified that the polymer jacket was detached/peeled, moreover the distal tip was bent.No further issues were confirmed in the analysis.
Event or Problem Description
It was reported that tip detachment occurred, and portion of the device fragment remained inside the patient.The target lesion was located in the non-tortuous and heavily calcified left anterior tibial artery.A v-14 control wire was selected for used.During procedure, the v-14 control wire was advanced along with a non-boston scientific catheter.It was noted that when the v-14 control wire was pulled back, the tip broke off in the patient.Part of the wire was unable to be retrieved and remained inside the patient.A second v-14 wire was advanced with non-boston scientific catheter and there was no issue.The procedure was not completed due to this event.No patient complications were reported.

• 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: 21276998
• Report Number: 2124215-2025-04453
• Device Sequence Number: 17044370
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• 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
• Device Implanted Year: 2024
• 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): 03/20/2025

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: 08/21/2026
• Device Model Number: H74939216730020
• Device Catalogue Number: H74939216730020
• Device Lot Number: 0034688797
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: COOK CXI.; MICROCATHETER: COOK CXI.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 113 KG