BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PLUS

    MDR report key: 3851691 · Received April 18, 2014

    Report

    Report Number
    2939520-2014-00030
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 29, 2014
    Manufacturer
    VOLCANO S.R.L.
    Product Code
    DQX
    PMA / PMN Number
    K111395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE (SN: (B)(4)) WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, ONE OTHER COMPLAINT (SN: (B)(4)) REGARDING THIS SAME LOT AND THIS SAME PROBLEM WAS FOUND. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO A DEVICE EVALUATION HAS NOT BEEN PERFORMED YET. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS THE FIRST GUIDEWIRE (SN: (B)(4)) USED IN THE PROCEDURE. AFTER PALIN OLD BALLOON ANGIOPLASTY (POBA) WHEN THE PHYSICIAN ATTEMPTED TO REMOVED THE BALLOON CATHETER, THE CATHETER GOT STUCK TO THE WIRE AND AS A RESULT, BOTH THE GUIDEWIRE AND CATHETER WAS REMOVED TOGETHER AS A SINGLE UNIT. A SECOND WIRE (SN: (B)(4)) WAS USED AND AFTER STENTING WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER, IT GOT STUCK TO THE WIRE AND THE DOCTOR GOT MAD. A THIRD WIRE WAS USED AND THE PROCEDURE WAS COMPLETED. AS PER THE ADDITIONAL INFORMATION PROVIDED, NO VISUAL DAMAGE WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE LESION TREATED WAS A TANDEM LESION, CORONARY #7 WITH 90% OCCLUSION AND HIGHLY CALCIFIED. AFTER CROSSING THE LESION, A SMALL RESISTANCE WAS FELT. THE DEVICE WAS NOT BROKEN INTO 2 PIECES AND NO PROTRUDING PARTS WERE OBSERVED. NO VESSEL OR OTHER INJURY WAS REPORTED AND THE PATIENT WAS DISCHARGED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238487 PRIMEWIRE PRESTIGE PLUS WIRE, GUIDE, CATHETER DQX VOLCANO S.R.L. 9185-01 0223 5007112

    Patients

    Seq Age Sex Outcome Treatment
    1