BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STREAK

    MDR report key: 17095 · Received September 16, 1994

    Report

    Report Number
    17095
    Event Type
    Injury
    Date Received
    September 16, 1994
    Date of Event
    September 9, 1994
    Report Date
    September 16, 1994
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN CARDIAC CATH LAB FOR PTCA OF LAD AND MAJOR DIAGONAL VIA RFA. DIAGONAL STENOSIS WAS ANGIOPLASTIED WITH GOOD RESULT. ATTENTION WAS THEN TURNED TO THE LAD. A 30 MM BALLOON DILATING CATHETER WAS ADVANCED TO SITE OF STENOSIS. TWO INFLATIONS WERE PERFORMED FOR A MAXIMUM DURATION OF 120 SECONDS TO A MAXIMUM PRESSURE OF 10 ATMOSPHERES. DURING THE SECOND INFLATION THE BALLOON RUPTURED AND WAS UNABLE TO BE REMOVED FROM THE CORONARY ARTERY. PT WAS REFERRED FOR EMERGENCY CABG SURGERY. THREE VESSEL CABG AND REMOVAL OF RETAINED ANGIO PLASTY BALLOON AND WIRE WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STREAK 30 MM BALLOON DILATING CATHETER LOX ADVANCED CARDIOVASCULAR SYSTEMS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R