BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE?

    MDR report key: 4799209 · Received May 27, 2015

    Report

    Report Number
    3008452825-2015-00036
    Event Type
    Injury
    Date Received
    May 27, 2015
    Report Date
    April 30, 2015
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DXO
    PMA / PMN Number
    K131452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) WARNS THAT TORQUING THE PRESSUREWIRE AGAINST RESISTANCE OR REPEATED ATTEMPTS TO CROSS A TOTAL VESSEL OCCLUSION MAY CAUSE DAMAGE AND/OR FRACTURE, WHICH MAY LEAD TO A PORTION OF PRESSUREWIRE SEPARATING FROM THE TIP. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) CAUTIONS TO ALWAYS ADVANCE OR WITHDRAW THE PRESSUREWIRE SLOWLY. NEVER PUSH, WITHDRAW OR TORQUE PRESSUREWIRE IF IT MEETS RESISTANCE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF SAUDI HEART ASSOCIATION: APRIL 2015; 27: 118-122. A (B)(6)-YEAR OLD FEMALE PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE, FOLLOWED BY AN FFR MEASUREMENT PROCEDURE IN THE LAD USING A PRESSUREWIRE. THE RADIO-OPAQUE TIP OF THE PRESSUREWIRE WAS BROKEN INSIDE THE LAD. UP TO THREE 0.014¿ FLOPPY GUIDEWIRES WERE UNSUCCESSFULLY USED TO FORM A HELIX TO RETRIEVE THE BROKEN TIP OF WIRE. DUE TO REPEATED MANIPULATION ATTEMPTS OF RETRIEVAL, THE BROKEN WIRE MIGRATED TO THE OBTUSE MARGINAL (OM2) ARTERY. AN ANGIOGRAPHIC CATHETER, NAMED SLIP-CATH, WAS THEN USED USING THE MOTHER-CHILD TECHNIQUE TO BE ABLE TO SUCCESSFULLY RETRIEVE THE BROKEN TIP OF THE PRESSUREWIRE. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. A POST-RETRIEVAL ANGIOGRAM DEMONSTRATED A TIMI (THROMBOLYSIS IN MYOCARDIAL INFARCTION) SCORE OF 3, SHOWING A BLOOD FLOW WITHOUT ANY COMPLICATIONS. DOI:10.1016/J.JSHA.2014.09.001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341401 PRESSUREWIRE? TRANSDUCER, PRESSURE, CATHETER TIP DXO ST. JUDE MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention