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

Model Number	H74939216930010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporters facility name - (b)(6).E1: initial reporters address 1 - (b)(6).
Event or Problem Description
It was reported that a tip break occurred, requiring an additional device.A 300cm v-14? control wire? was selected for use during a below the knee angioplasty procedure.The target lesion was greater than 90% stenosed, was moderately calcified and mildly tortuous.During the procedure, the tip of the wire broke while removing the device from the body post angioplasty.It was noted that the device was outside the body at the time of the fracture, and it was also noted that the device was removed intact with the help of a diagnostic catheter.A new v-14 control wire was used.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporters facility name: (b)(6).E1: initial reporters address 1: (b)(6).
Event or Problem Description
It was reported that tip break occurred, requiring an additional device.A 300cm v-14? control wire? was selected for use during a below the knee angioplasty procedure.The target lesion was greater than 90% stenosed, was moderately calcified and mildly tortuous.During the procedure, the tip of the wire broke while removing the device from the body post angioplasty.It was noted that the device was outside the body at the time of the fracture, and it was also noted that the device was removed intact with the help of a diagnostic catheter.A new v-14 control wire was used.There were no patient complications as a result of this event.It was reported that only the tip of the wire broke.When the physician retracted the damaged v-14 wire with the help of a catheter, she was able to visualize the extent of the damage.Advancing the balloon over the damaged wire was difficult and it did not provide adequate support, so the wire was removed and replaced with a new one.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that tip break occurred, requiring an additional device.A 300cm v-14? control wire? was selected for use during a below the knee angioplasty procedure.The target lesion was greater than 90% stenosed, was moderately calcified and mildly tortuous.During the procedure, the tip of the wire broke while removing the device from the body post angioplasty.It was noted that the device was outside the body at the time of the fracture, and it was also noted that the device was removed intact with the help of a diagnostic catheter.A new v-14 control wire was used.There were no patient complications as a result of this event.It was further reported that only the tip of the wire broke.When the physician retracted the damaged v-14 wire with the help of a catheter, she was able to visualize the extent of the damage.Advancing the balloon over the damaged wire was difficult and it did not provide adequate support, so the wire was removed and replaced with a new one.It was further reported that the device was removed from the patients body with the assistance of a diagnostic catheter.The tip was observed to be detached upon removal of the diagnostic catheter in the sterile field.

• 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: 23536255
• Report Number: 2124215-2025-81162
• Device Sequence Number: 18692664
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: (01)08714729799269(17)261122(10)35343897
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2026

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: H74939216930010
• Device Catalogue Number: H74939216930010
• Device Lot Number: 0035343897
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 01/18/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/08/2025; 02/16/2026
• Date Device Manufactured: 11/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown