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

Model Number	H74939216730010
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in a mildly tortuous and moderately calcified tibial artery.A 2.5mm x 60mm x 150cm coyote balloon catheter and 300cm v-14 control wire guidewire were selected for tibial angioplasty.However, it was noted that the guidewire and balloon had become fused during the procedure, requiring both devices to be pulled and removed as a single unit.The balloon was removed in a fully deflated state.The procedure was completed using an alternate device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in a mildly tortuous and moderately calcified tibial artery.A 2.5mm x 60mm x 150cm coyote balloon catheter and 300cm v-14 control wire guidewire were selected for tibial angioplasty.However, it was noted that the guidewire and balloon had become fused during the procedure, requiring both devices to be pulled and removed as a single unit.The balloon was removed in a fully deflated state.The procedure was completed using an alternate device.There were no patient complications as a result of this event.It was further reported that the balloon had difficulty advancing over the wire.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in a mildly tortuous and moderately calcified tibial artery.A 2.5mm x 60mm x 150cm coyote balloon catheter and 300cm v-14 control wire guidewire were selected for tibial angioplasty.However, it was noted that the guidewire and balloon had become fused during the procedure, requiring both devices to be pulled and removed as a single unit.The balloon was removed in a fully deflated state.The procedure was completed using an alternate device.There were no patient complications as a result of this event.It was further reported that difficulty advancing balloon over the wire occurred.
Additional Manufacturer Narrative
H6 - evaluation conclusion code: updated.

• 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 MN ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23959931
• Report Number: 2124215-2026-00320
• Device Sequence Number: 5611403
• Product Code: DQX
• UDI-Device Identifier: 08714729799221
• UDI-Public: (01)08714729799221(17)270918(10)37483872
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: H74939216730010
• Device Catalogue Number: H74939216730010
• Device Lot Number: 0037483872
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 01/14/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/15/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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 Age: 72 YR
• Patient Sex: Male