BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 7.5 FR 40 CC IAB

    MDR report key: 2221593 · Received August 19, 2011

    Report

    Report Number
    2248146-2011-00468
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    "RUPTURED" BALLOON, BLOOD IN TUBING. "PT CARE GREATLY AFFECTED." IT WAS STATED THAT THE PT WAS ON ANOTHER ASSIST DEVICE AND THE BALLOON WAS INSERTED THROUGH A FEMORAL CUT DOWN. F/U WITH SALES REP CONFIRMED NO DEATH ASSOCIATED WITH THIS CASE, HOWEVER, IT WAS TREATED AS A "SENTINEL EVENT." HOSP IS NOT RELEASING IAB AT THE MOMENT AND NO NEW INFO IS BEING PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR 7.5 FR 40 CC IAB INTRA-AORTIC BALLOON DSP DATASCOPE CORP 0684-00-0475 2600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK