BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 1983852 · Received February 4, 2011

    Report

    Report Number
    1219856-2011-00047
    Event Type
    Death
    Date Received
    February 4, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT HAD AN INTRA-AORTIC BALLOON (IAB) INSERTED FOR A STEMI 4 HOURS PRIOR. THE INSERTION PROCEDURE HAD NO ISSUES. THE PUMP ALARMED AND THE NURSE FOUND BLOOD IN THE LINE. THE VASCULAR SURGEON REMOVED AND REPLACED THE CATHETER SUCCESSFULLY. THERE WAS NO PATIENT DEATH OR INJURIES. THE COMPLICATION OF BLEEDING IS NOTED AND THE PATIENT REMAINS ON IAB THERAPY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE DISTRIBUTOR STATED, THE BLOOD LOSS WAS NOT SEVERE. IT DID NOT CAUSE BLOOD PRESSURE TO DROP NOR REQUIRE A TRANSFUSION. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2011 INDICATED, THE PATIENT HAD BEEN IN REALLY BAD CONDITION AND HAVE BEEN USING IAB FOR A WEEK; HE PASSED AWAY LAST WEEK. THE PATIENT'S DEATH WAS NOT RELATED TO THE DEFAULT PRODUCT, BUT THE PATIENT'S OWN POOR CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death INTRA-AORTIC BALLOON PUMP