BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE CERTUS

    MDR report key: 2792195 · Received October 10, 2012

    Report

    Report Number
    8030904-2012-00012
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ST. JUDE MEDICAL SYSTEMS AB
    Product Code
    DXO
    PMA / PMN Number
    K113584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE PT WITH NSTEMI AND TWO VESSEL CORONARY HEART DISEASE UNDERWENT FRACTIONAL FLOW RESERVE (FFR) MEASUREMENT TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A PRESSUREWIRE CERTUS WAS INSERTED THROUGH THE RADIAL ACCESS AND A 6F XB CORDIS GUIDING CATHETER TO THE MID LAD. THE FLOPPY TIP OF THE PRESSUREWIRE TRACKED INTO A SMALL LATERAL BRANCH AND THEN BECAME FIXED WITH NO FURTHER MOVEMENT OR MANIPULATION. MULTIPLE ATTEMPTS WERE MADE BY THE PHYSICIAN TO REMOVE THE GUIDEWIRE WHICH WAS FINALLY REMOVED FORM THE VESSEL. WHEN THE PRESSUREWIRE CERTUS WAS PULLED BACK, THE FLOPPY TIP TORE OFF AND REMAINED IN THE VESSEL. THE PT UNDERWENT BYPASS SURGERY AND REMAINED STABLE DURING AND AFTER THE OPERATION. THE SURGEON COMMENTED THAT THE REMAINDER OF THE GUIDEWIRE WAS DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSUREWIRE CERTUS GUIDEWIRE SENSOR DXO ST. JUDE MEDICAL SYSTEMS AB C12008 123760

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention