MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
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	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire bifurcation occurred.A 300cm, 8cm v-18 control wire was selected for use in a balloon angioplasty.During the procedure, the distal end of the guidewire was observed to be bifurcated.The procedure was completed with a new hydrophilic-coated steerable guidewire.No patient complications or harm were reported as a result of this event.
Additional Manufacturer Narrative
E1: initial reporters phone number: (b)(6).
Additional Manufacturer Narrative
E1: (b)(6).A1, a2, a4: patient information updated - patient identifier, date of birth, age, weight.
Event or Problem Description
It was reported that guidewire bifurcation occurred.A 300cm, 8cm v-18 control wire was selected for use in a balloon angioplasty.During the procedure, the distal end of the guidewire was observed to be bifurcated.The procedure was completed with a new hydrophilic-coated steerable guidewire.No patient complications or harm were reported as a result of this event.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24261269
• Report Number: 2124215-2026-06469
• Device Sequence Number: 7976269
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: (01)08714729070207(17)270110(10)35598463
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033742
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0035598463
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/12/2026
• Date Device Manufactured: 01/10/2025
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 70 KG