BEUDAMED
    FDA Adverse Event Death Summary report: N

    REDI-GUARD WITH ARMOR GLIDE

    MDR report key: 31595 · Received February 1, 1996

    Report

    Report Number
    31595
    Event Type
    Death
    Date Received
    February 1, 1996
    Date of Event
    December 28, 1995
    Report Date
    January 17, 1996
    Manufacturer
    ST. JUDE MEDICAL,INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH CORONARY ARTERY DISEASE AND MYOCARDIAL INFARCTION WAS IN CARDIOGENIC SHOCK. ANGIOPLASTY OF THE ANTERIOR TRUNK WAS DONE AND PT PLACED ON BALLOON PUMP. PUMP CATHETER FAILED NECESSITATING A SECOND CATHETER INSERTION. RPTR WAS UNABLE TO REMOVE THE FIRST CATHETER BECAUSE IT WOULD NOT COME OUT. PT DIED SHORTLY THEREAFTER. POST SHOWED AN 1" BY 1" BLOOD CLOT. FEEL THAT THERE WAS SOME KIND CATHETER LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDI-GUARD WITH ARMOR GLIDE Implant INTRA-AORTIC BALLOON PUMP DSP ST. JUDE MEDICAL,INC. 40CC9FRRDG11 INTRODUCER *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death