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

Model Number	40458
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal tip fractured and remained inside the patient.Vascular access was obtained via contralateral approach.The 100% stenosed target lesion was located in the severely calcified and moderate to severely tortuous superficial femoral artery (sfa).A 300cm v-14 control wire and a 130cm eluvia drug-eluting vascular stent system were selected for a peripheral revascularization procedure.The lesion was predilated.During the procedure, the distal tip of the v-14 control wire fractured and remained in a subintimal channel in the sfa.Throughout the entire procedure, friction occurred in the systems.During deployment, lots of force was required to deploy the stent.Fifty percent of the stent was deployed when the event occurred.Pulling the pull grip and pulling back on the delivery system ultimately deployed the stent.The stent stretched and fractured.The stent was not removed from the patient and remained in the vessel.The stent was post dilated.No kinks were observed.The non-boston scientific guidewire and the stent delivery system were intact and removed together from the patient.A non-boston scientific.014 guidewire was used to complete the procedure.The procedure was completed successfully and patient's foot was looking better than prior to the procedure.The patient will continued to be followed with more frequent imaging.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received and the polymer jacket and wire were detached and the distal tip was kinked.No other issues were noted in the device.Microscopic inspection confirmed the polymer jacket and wire were detached and the distal tip was kinked.The outer diameter of the device was measured in the distal, medium, and proximal sections and was within specification.Only 8.5cm of the distal tip was returned attached to the device distal section, therefore, 2.5cm was detached and not returned.No discernible defect or damage was identified on the provided photos.
Event or Problem Description
It was reported that the distal tip fractured and remained inside the patient.Vascular access was obtained via contralateral approach.The 100% stenosed target lesion was located in the severely calcified and moderate to severely tortuous superficial femoral artery (sfa).A 300cm v-14 control wire and a 7x120, 130cm eluvia drug-eluting vascular stent system were selected for a peripheral revascularization procedure.The lesion was predilated.During the procedure, the distal tip of the v-14 control wire fractured and remained in a subintimal channel in the sfa.Throughout the entire procedure, friction occurred in the systems.During deployment, lots of force was required to deploy the stent.Fifty percent of the stent was deployed when the event occurred.Pulling the pull grip and pulling back on the delivery system ultimately deployed the stent.The stent stretched and fractured.The stent was not removed from the patient and remained in the vessel.The stent was post dilated.No kinks were observed.The non-boston scientific guidewire and the stent delivery system were intact and removed together from the patient.A non-boston scientific.014 guidewire was used to complete the procedure.The procedure was completed successfully and patient's foot was looking better than prior to the procedure.The patient will continued to be followed with more frequent imaging.There were no patient complications.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13459356
• Report Number: 2134265-2022-00954
• Device Sequence Number: 6199734
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 03/11/2022

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: 07/30/2023
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0027756936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE SHEATH: 6 FRENCH TERUMO DESTINATION; GUIDE SHEATH: 6 FRENCH TERUMO DESTINATION; GUIDEWIRE: .035 TERUMO GLIDEWIRE ADVANTAGE; GUIDEWIRE: .035 TERUMO GLIDEWIRE ADVANTAGE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White