BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-18¿ CONTROL WIRE¿

    MDR report key: 2970419 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-00827
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE DEVICE WAS BENT 296.6CM FROM THE PROXIMAL END, AND KINKED 299.1CM FROM THE PROXIMAL END. ALL THE MEASUREMENTS THAT WERE TAKEN WERE WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER FROZE ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THIS V-18 CONTROL WIRE WAS SELECTED; HOWEVER DURING ADVANCEMENT THE NON-BSC BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE CATHETER FROZE ON THE GUIDE WIRE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THIS V-18 CONTROL WIRE WAS SELECTED; HOWEVER, DURING ADVANCEMENT THE NON-BSC BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74676 V-18¿ CONTROL WIRE¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001468540 14435043

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER: GENITY OTW 4-20