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

Model Number	H74939216730010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire detachment occurred, and additional intervention was performed.The 60 to 70% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery (sfa) to proximal artery.A 300cm straight tip v-14 control wire was used for treatment.During the procedure, the physician attempted to advance this guidewire through a non-bsc guiding catheter in order to cross the lesion.The physician encountered difficulty in crossing the lesion and applied pressure and torque to the proximal end of the guidewire in an effort to navigate through the calcified area.Subsequently, it was observed that the distal spring coil segment of the guidewire, measuring approximately 2 to 3 cm, had detached.The detached portion of the guidewire was successfully snared and retrieved intact.The procedure was then completed using an alternative device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the 300cm straight tip v-14 control wire was not returned for analysis.Although media was provided in the parent record and it was verified that the information on the box and pouch matched the details of the complaint, this does not substantiate the reported issue of distal tip detachment of the device or its component.Consequently, the complaint event cannot be confirmed due to the absence of a returned device or a comprehensive media review that could identify any issues supporting the alleged claim.
Event or Problem Description
It was reported that guidewire detachment occurred, and additional intervention was performed.The 60 to 70% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery (sfa) to proximal artery.A 300cm straight tip v-14 control wire was used for treatment.During the procedure, the physician attempted to advance this guidewire through a non-bsc guiding catheter in order to cross the lesion.The physician encountered difficulty in crossing the lesion and applied pressure and torque to the proximal end of the guidewire in an effort to navigate through the calcified area.Subsequently, it was observed that the distal spring coil segment of the guidewire, measuring approximately 2 to 3 cm, had detached.The detached portion of the guidewire was successfully snared and retrieved intact.The procedure was then completed using 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21930144
• Report Number: 2124215-2025-26506
• Device Sequence Number: 15724993
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)261115(10)35291180
• 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): 06/16/2025

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: H74939216730010
• Device Catalogue Number: H74939216730010
• Device Lot Number: 0035291180
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 11/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDING CATHETER - 6 FR MPA; GUIDING CATHETER - 6 FR MPA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female