MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40535
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion, which was 100% stenosed, was situated in the moderately tortuous and severely calcified right superficial femoral artery.A 300 cm, 12 cm poly tip v-18 control wire was utilized during the procedure.During the intervention, the wire was knuckled and lased, however, it was observed that the distal tip of the wire became detached.A covered stent was used placed as a result.The procedure was subsequently completed using an alternative device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion, which was 100% stenosed, was situated in the moderately tortuous and severely calcified right superficial femoral artery.A 300 cm, 12 cm poly tip v-18 control wire was utilized during the procedure.During the intervention, the wire was knuckled and lased, however, it was observed that the distal tip of the wire became detached.A covered stent was used placed as a result.The procedure was subsequently completed using an alternative device.There were no patient complications as a result of this event.It was further reported that a stent was implanted to cover and trap the detached tip.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Device evaluated by mfr: the device was returned for analysis.Upon examination of the returned guidewire, it was noted that the guidewire was bent and had detached at the distal tip.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion, which was 100% stenosed, was situated in the moderately tortuous and severely calcified right superficial femoral artery.A 300 cm, 12 cm poly tip v-18 control wire was utilized during the procedure.During the intervention, the wire was knuckled and lased, however, it was observed that the distal tip of the wire became detached.A covered stent was used placed as a result.The procedure was subsequently completed using an alternative device.There were no patient complications as a result of this event.It was further reported that a stent was implanted to cover and trap the detached tip.

• Brand Name: V-18 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: 21643518
• Report Number: 2124215-2025-16685
• Device Sequence Number: 15359808
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: (01)08714729070238
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K033742
• 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,Followup
• Report Date (Section B): 07/08/2025

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 Model Number: 40535
• Device Catalogue Number: 40535
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 06/11/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/21/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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