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

Model Number	40456
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detached and remained in the patient.A 300cm v-14 guidewire was selected for use in a below-the-knee percutaneous transluminal angioplasty procedure in the posterior dorsalis pedis.A rubicon 14 was advanced over the v-14 guidewire.After withdrawing the v-14 guidewire from the rubicon 14, it was observed that part of the guidewire tip remained in the foot.Additional intervention was performed.However, attempts to retrieve the guidewire tip were unsuccessful.The procedure was not completed.No patient complications were reported.
Additional Manufacturer Narrative
Media analysis: the device was not returned for analysis; however, a photo was provided.It was observed that the polymer jacket was detached.Additionally, it was noted that the core wire was bent and kinked.
Event or Problem Description
It was reported that the tip detached and remained in the patient.A 300cm v-14 guidewire was selected for use in a below-the-knee percutaneous transluminal angioplasty procedure in the posterior dorsalis pedis.A rubicon 14 was advanced over the v-14 guidewire.After withdrawing the v-14 guidewire from the rubicon 14, it was observed that part of the guidewire tip remained in the foot.Additional intervention was performed.However, attempts to retrieve the guidewire tip were unsuccessful.The procedure was not completed.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: 19618367
• Report Number: 2124215-2024-39044
• Device Sequence Number: 17879664
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: 08714729799221
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 11/27/2025
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0032944405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• 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