BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEGA 8FR 50CC IAB

    MDR report key: 3946236 · Received July 2, 2014

    Report

    Report Number
    2248146-2014-00215
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THERE WAS A DIFFICULT INSERTION WITH MEGA 50 THROUGH OUT SHEATH. THIS WAS A (B)(6) YEARS OLD MALE ARREST. THEY EVENTUALLY GOT THE IAB IN AFTER USING ANOTHER SHEATH. THE PT EXPIRED SEVERAL HOURS LATER. THIS WAS NOT ATTRIBUTED TO THE IAB. UPDATE PHONE CALL WITH THE SALES REP ON (B)(6) 2013: BALLOON UNFURLED AND WAS DIFFICULT TO INSERT. THEY USED ANOTHER SHEATH AND BALLOON INSERTED. STATED AGAIN, THAT THE BALLOON WAS NOT THE CAUSE OF DEATH. PT WAS ALREADY FLAT-LINED WHEN PUTTING CATHETER IN. PT DIED: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385302 MEGA 8FR 50CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP. 0684-00-0497

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death