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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14 CONTROL WIRE; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION V-14 CONTROL WIRE; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 40456
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 08/13/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient underwent pedal stick to do a retrograde tibial vessel percutaneous transluminal angioplasty (pta).The 100% stenosed target lesion was located in the severely calcified tibial vessel.Two 182cm straight tip v-14 control wire were selected for use.However, upon trying to cross the chronic totally occluded lesion, the tip of both guidewires were fractured.The physician used a tibial balloon to capture the fractured pieces and completely removed it.Nothing was left behind and the procedure was completed successfully.No patient complications were reported.
 
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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 Key12389019
Report Number2134265-2021-10878
Device Sequence Number4648747
Product Code DQX
UDI-Device Identifier08714729799207
UDI-Public08714729799207
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K112745
Number of Events Summarized1
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
Report Date (Section B) 08/30/2021
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 Date04/06/2023
Device Model Number40456
Device Catalogue Number40456
Device Lot Number0027093169
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/13/2021
Initial Report FDA Received Date08/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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