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	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred requiring additional intervention.The patient presented with peripheral artery disease.The 100% stenosed target lesion was located in the mildly tortuous, severely calcified and chronic totally occluded tibial artery.A 300cm angled tip v-14 control wire guidewire was advanced for use.However, during the procedure, the tip of the wire broke off in the vessel.The physician tried to snare it, but it was too embedded and could not be retrieved.The procedure was completed and no patient complications were reported and the patient was fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned.It was observed through visual and microscopic inspection, that the distal tip was detached, and the wire was kinked at the distal section.No more damages or issues were observed.
Event or Problem Description
It was reported that tip detachment occurred requiring additional intervention.The patient presented with peripheral artery disease.The 100% stenosed target lesion was located in the mildly tortuous, severely calcified and chronic totally occluded tibial artery.A 300cm angled tip v-14 control wire guidewire was advanced for use.However, during the procedure, the tip of the wire broke off in the vessel.The physician tried to snare it, but it was too embedded and could not be retrieved.The procedure was completed and no patient complications were reported and the patient was fully recovered.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16581813
• Report Number: 2124215-2023-09625
• Device Sequence Number: 4747592
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: 11/27/2024
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0030615645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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