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 Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient presented with critical limb ischemia and underwent angiogram.The target lesion was located in the common femoral patch with lots of scar tissue.A 150cm, 8cm v-18 control wire was used for access.However, the tip of the wire broke off inside the vessel of the patient during attempted access.There procedure was completed with a different device.There were no further patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: (media inspection) the complaint device was not returned by the customer, nevertheless the customer did provide pictures related to the complaint, where is possible to observe an x-ray, however, there is no visible evidence that the device was broken at the photo attached.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient presented with critical limb ischemia and underwent angiogram.The target lesion was located in the common femoral patch with lots of scar tissue.A 150cm, 8cm v-18 control wire was used for access.However, the tip of the wire broke off inside the vessel of the patient during attempted access.There procedure was completed with a different device.There were no further patient complications reported.It was further reported that the physician did not attempt to remove the dislodged wire due to leg pain/ limb salvage.Additionally, common femoral artery was the final location of the detached wire after it broke.

• Brand Name: V-18 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: 14310725
• Report Number: 2134265-2022-04922
• Device Sequence Number: 5223406
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 12/13/2023
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0028545943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown