BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULLINS BALLON (ANGIOPLASTY)

    MDR report key: 22750 · Received May 22, 1995

    Report

    Report Number
    22750
    Event Type
    Death
    Date Received
    May 22, 1995
    Date of Event
    March 7, 1995
    Report Date
    May 19, 1995
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A 28 YR OLD PT WITH LENGTHY & COMPLEX HISTORY OF CONGENITAL HEART DISEASE REQUIRED BALLOON ANGIOPLASTY IN HEROIC ATTEMPT TO IMPROVE BLOOD FLOW TO LUNG VIA SHUNT WHICH HAD BECOME NARROWED SINCE 1987 ANGIOPLASTY. INITIAL ATTEMPT WITH STANDARD 12MM HIGH PRESSURE BALLOON WAS UNSUCCESSFUL AS BALLOON NOT LARGE ENOUGH TO OPEN THE NARROWING. CATHETERIZATION WAS THEN ATTEMPTED WITH SPECIALLY ORDERED BALLOON WHICH WAS 16MM IN DIAMETER BUILT TO WITHSTAND 12-15 ATMOSPHERES OF PRESSURE. THESE BALLOONS ARE USED ONLY IN CASES WHERE THERE ARE NO AVAILABLE ALTERNATIVES FOR PTS. AT APPROX 11 & 1/2 ATMOSPHERES OF PRESSURE THE BALLOON RUPTURED. WITHDRAWAL OF THE RUPTURED BALLOON WAS EXTREMELY DIFFICULT & ACCOMPLISHED ONLY AFTER APPROX 1 HR AT WHICH POINT IT BECAME CLEAR THAT THE DISTAL PORTION OF THE CATHETER & THE BALLOON WERE NOT PRESENT. THE METALLIC MARKER WHICH IS INTENDED TO MAKE THE BALLOON VISIBLE ON FLUOROSCOPY DID COME OUT SO IT WAS NOT PRESENT TO ASSIST IN ASCERTAINING THE LOCATION OF THE REMAINING PORTION OF THE BALLOON. IT WAS BELIEVED TO BE JUST BELOW THE SKIN. APPROX 2 HRS AFTER THE PROCEDURE THE PT DEVELOPED RAPIDLY PROGRESSIVE INCREAS IN CYANOSIS & DECREASE IN OXYGENATION. HE DEVELOPED CARDIORESPIRATORY ARREST & DIED. ON AUTOPSY IT WAS DETERMINED THAT THE DISTAL PORTION OF THE BALLOON HAD REMAINED IN THE SHUNT & CAUSED THE OXYGEN LEVEL TO HIS LUNGS TO DECREASE, RESULTING IN HIS CARDIOPULMONARY ARREST. IT HAD PREVIOUSLY BEEN DETERMINED THAT THERE WERE NO FURTHER SURGICAL PROCEDURES WHICH COULD BE OFFERED TO THIS PT. PT HAD SLOW CONSISTENT DETERIORATION IN EXERCISE TOLERANCE DUE TO POLYCYTHEMIA & DECREASING LEFT VENTRICULAR FUNCTION. RECENT ADMISSION FOR RIGHT AXILLARY VEIN THROMBUS, SUCCESSFULLY TREATED WITH HEPARIN + COUMADIN. THIS ADMISSION RESOLVED WITH EXCHANGE TRANSFUSION & UROKINASE. CARDIAC CATHETERIZATION PERFORMED TO ASSESS HEMODYNAMICS OF THE RIGHT PULMONARY ARTERIAL CIRCULATION & PERFORM BALLOON ANGIOPLASTY OF THE SCV-RPA JUNCTION OR OF THE AORTA-SUPERIOR VENA CAVAL JUNCTION TO AUGMENT PULMONARY BLOOD FLOW & IMPROVE EXERCISE TOLERANCE & HYPERCOAGULABILITY BY REDUCING DEVELOPMENT OF POLYCYTHEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULLINS BALLON (ANGIOPLASTY) BALLOON LIT NUMED, INC. Z-0118

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death