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

Model Number	H74939216930010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort has been sent to confirm the patient outcome and if the stent was removed; however, has not been obtained at the time this report was sent.B3: date of event - used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that the wire tip broke off.The stenosed target lesion was located in the mildly tortuous and fibrotic calcified vessel.A v-14 control wire was used for treatment.During the procedure, while the device was being advanced across the lesion, it was observed that the wire tip fractured.The detached wire tip was later found in the patient's lung.The procedure was completed with an alternative device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Good faith effort has been sent to confirm the patient outcome and if the stent was removed; however, has not been obtained at the time this report was sent.B3: date of event - used the first date of the month of the aware date as no event date was provided.The v-14 control wire was not returned for analysis; however, photos were attached in the parent record, and it's not possible to clearly see the device and the reported issue.
Event or Problem Description
It was reported that the wire tip broke off.The stenosed target lesion was located in the mildly tortuous and fibrotic calcified vessel.A v-14 control wire was used for treatment.During the procedure, while the device was being advanced across the lesion, it was observed that the wire tip fractured.The detached wire tip was later found in the patient's lung.The procedure was completed with an alternative device.There were no patient complications as a result of this event.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21688896
• Report Number: 2124215-2025-17676
• Device Sequence Number: 18450343
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: (01)08714729799269
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/03/2025

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: H74939216930010
• Device Catalogue Number: H74939216930010
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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 Sex: Unknown