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

Model Number	40456
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.A 182cm straight tip v-14 control wire guidewire was selected for use.However, the wire snapped in half while pulling the wire out of the hoop.The procedure was completed with another v14 guidewire.No patient complications nor injuries reported.
Additional Manufacturer Narrative
Device eval by mfr: the returned device matched with upn provided by the customer.Visual inspection of the returned guidewire had the middle section bent and wire broken.No issue was revealed with the polymer jacket.Dimensional inspection revealed the outer diameter of the distal, medium and proximal were within specification.
Event or Problem Description
It was reported that guidewire fracture occurred.A 182cm straight tip v-14 control wire guidewire was selected for use.However, the wire snapped in half while pulling the wire out of the hoop.The procedure was completed with another v14 guidewire.No patient complications nor injuries reported.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11340256
• Report Number: 2134265-2021-01894
• Device Sequence Number: 3372479
• Product Code: DQX
• UDI-Device Identifier: 08714729799207
• UDI-Public: 08714729799207
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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 Expiration Date: 10/17/2021
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0024622787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1