BEUDAMED
    FDA Adverse Event Death Summary report: N

    OCCLUSION BALLOON CATHETER

    MDR report key: 33531 · Received May 22, 1996

    Report

    Report Number
    33531
    Event Type
    Death
    Date Received
    May 22, 1996
    Date of Event
    May 20, 1996
    Report Date
    May 21, 1996
    Manufacturer
    INTERVENTINAL THERAPEUTICS CORP.
    Product Code
    HBZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF A CEREBRAL ANGIOGRAM AND BALLOON OCCLUSION OF THE BASILAR ARTERY, THE PT'S ANEURYSM RUPTURED AND THE PT UNDERWENT A RESPIRATORY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCLUSION BALLOON CATHETER OCCLUSION BALLOON CATHETER HBZ INTERVENTINAL THERAPEUTICS CORP. 9598

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death DASHER .14 STEERABLE GUIDE WIRE ITC 7.3 FR| INTRODUCER CATHETER SET