BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE PRESTIGE PLUS

    MDR report key: 3851689 · Received April 18, 2014

    Report

    Report Number
    2939520-2014-00028
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    January 21, 2014
    Report Date
    March 26, 2014
    Manufacturer
    VOLCANO S.R.L.
    Product Code
    DQX
    PMA / PMN Number
    K111395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT STUCK IN A LESION OR STENT AND NO INJURY TO THE PATIENT WAS REPORTED. . THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, THERE IS NO OTHER COMPLAINT REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. 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 THE WIRE WAS USED FOR AN UNUSUAL MEASUREMENT. THE GUIDEWIRE (PRESTIGE PLUS) WAS NOT MOVED DURING THE PTCA PROCEDURE BUT WHEN THE WIRE WAS ADVANCED IN THE DISTAL LAD (LEFT ANTERIOR DESCENDING, CORONARY ARTERY) HOWEVER, NO STENOSIS WAS OBSERVED AT THIS PART OF THE VESSEL. AFTER THE PROCEDURE, IT WAS DETECTED THAT NO WIRE TIP COULD NE SEEN ON THE ANGIOGRAM. THE WIRE WAS REMOVED OUT OF THE VESSEL BUT IT WAS OBSERVED THAT THE WIRE TIP WAS ALMOST PULLED LIKE A FIBER IN TENSION BUT NOT DISRUPTED. NO OTHER WIRE WAS USED. AS PER THE ADDITIONAL INFORMATION PROVIDED, NO VISUAL DAMAGE WAS OBSERVED WHEN DEVICE WAS REMOVED FORM THE PACKAGING AND DURING PREPARATION. A SMALL RESISTANCE WAS FELT WHEN WIRE WAS MOVED FORWARD TO THE DISTAL VESSEL. HOWEVER, NO TORTUOUSNESS OR ANY VISUAL VESSEL ISSUE WAS OBSERVED. AN INTRODUCER WAS USED TO SHAPE THE WIRE. THE DEVICE WAS NOT STUCK IN A LESION OR STENT AND NO INJURY TO THE PATIENT WAS REPORTED. THE DEVICE WAS NOT BROKEN INTO 2 PIECES AND NO PROTRUDING PARTS WERE OBSERVED. ALL PORTION OT HE WIRE WAS ACCOUNTED FOR WHEN REMOVED FORM THE PATIENT. THE PATIENT WAS DISCHARGED AS EXPECTED AND IS CURRENTLY IN GOOD CONDITION. NOTE: DETAILS OF PTCA PROCEDURE: ANGIOPLASTY IS PERFORMED TO OPEN A NARROWED CORONARY ARTERY, IN WHICH A BALLOON-TIPPED CATHETER IS INSERTED INTO A ARTERY IN THE GROIN OR SHOULDER AND THREADED TO THE AFFECTED PART. THE BALLOON IS INFLATED TO FLATTEN ATHEROSCLEROTIC PLAQUE AGAINST THE ARTERY WALL AND REOPEN THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238458 PRIMEWIRE PRESTIGE PLUS WIRE, GUIDE, CATHETER DQX VOLCANO S.R.L. 9185 0110 5004765

    Patients

    Seq Age Sex Outcome Treatment
    1