MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 Control Wire; wire, guide, catheter

Model Number	40535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device detachment occurred.A v-18 control wire was selected for use during an obliterative arteriopathy of the lower extremities, which required angioplasty of the proximal fibular artery.During the procedure, a fragment of the guidewire detached and remained in the patients popliteal artery.It was noted that the fragment was not retrieved because it was microscopic and deemed harmless by the doctors.The patient was discharged and prescribed a 7 day treatment with antibiotics (augmentin).No changes were made to the anticoagulant treatment.
Additional Manufacturer Narrative
Further event 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 specific product information.If additional details become available, a supplemental report will be submitted.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50587899
• Report Number: 2124215-2026-46544
• Device Sequence Number: 15875791
• Product Code: DQX
• UDI-Device Identifier: 08714729070221
• UDI-Public: (01)08714729070221(17)280325(10)38929989
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40535
• Device Catalogue Number: 40535
• Device Lot Number: 0038929989
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 03/26/2026
• 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
• Patient Age: 74 YR
• Patient Sex: Unknown