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

Model Number	40458
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fractured at the tip inside the patient.This v-14 control wire was selected for dilatation of dialysis shunt in the arcus palmaris superficialis.The vessel was 80% stenosed with severe calcification and moderate tortuosity.During the placement of this guidewire through the stenosis, when the physician pulled back, the tip broke.A snare was used to try to remove the guidewire, however it was only partially able to be explanted and a portion remains implanted.No patient complications were reported, and the procedure was not able to be completed.
Additional Manufacturer Narrative
Device eval by manufacturer: this product was not returned for analysis, as the device was disposed of by the physician.An x-ray was submitted for review that confirmed the distal end of the guidewire was detached/separated from the rest of the device.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15378171
• Report Number: 2124215-2022-32570
• Device Sequence Number: 12119905
• Product Code: DQX
• UDI-Device Identifier: 08714729799252
• UDI-Public: 08714729799252
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2022

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 Expiration Date: 08/02/2023
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0027765463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown