BEUDAMED
    FDA Adverse Event Death Summary report: N

    940 INTRA-AORTIC BALLOON CATHETER

    MDR report key: 75927 · Received March 14, 1997

    Report

    Report Number
    1220076-1997-00015
    Event Type
    Death
    Date Received
    March 14, 1997
    Date of Event
    February 8, 1997
    Report Date
    February 14, 1997
    Manufacturer
    CARDIAC ASSIST A DIV. OF BOSTON SCIENTIFIC CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LESS THAN 24 HRS POST-PLACEMENT OF THIS INTRA-AORTIC BALLOON CATHETER, ANOTHER MFR'S INTRA-AORTIC BALLOON PUMP'S OPACITY ALARM SOUNDED. NO BLOOD IN THE TUBING WAS NOTED AND COUNTERPULSATION RESUMED. ON 2/10, TWO DAYS LATER, THE OPACITY ALARM SOUNDED AGAIN. TUBING WAS AGAIN INSPECTED AND BLOOD WAS NOTED AND COUNTERPULSATION RESUMED. ON 2/12, THE PT CODED AND BLOOD WAS NOTED IN THE TUBING AT THE TIME. FOLLOW UP COULD NOT CONFIRM IF RESUSCITATIVE EFFORTS WERE EMPLOYED, HOWEVER, THE PT EXPIRED. NO FURTHER DETAILS REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT WERE AVAILABLE. THE DEVICE WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL INDICATED DRIED BLOOD WAS NOTED IN THE ATTACHED TUBING AND MALE LUER. THE BALLOON AND SHAFT CONTAINED LARGE QUANTITIES OF BLOOD. THE SHAFT WAS SEVERELY BENT IN NUMEROUS LOCATIONS. THE SHEATH WAS ALSO NOTED TO BE KINKED IN SEVERAL PLACES. THE BALLOON WAS SOAKED IN WARM WATER AND A LEAK WAS OBSERVED AT THE DISTAL END OF THE BALLOON. MICROSCOPIC EXAM REVEALED TWO LENGTHWISE SLICES IN THE BALLOON APPROX 2MM IN LENGTH AND 1MM APART LOCATED 5.3CM FROM THE DISTAL TIP. SCRATCHES ON THE BALLOON SURFACE SURROUNDING THE PUNCTURE SITE WERE NOTED. THE SLICES WERE CLEAN AND SMOOTH. IABC LEAKS HAVE BEEN ASSOCIATED WITH REPEATED CYCLING AGAINST CALCIFIED LESIONS AND/OR OTHER HARD, SHARP MATERIAL. SCRATCHES ON THE BALLOON SURFACE SURROUNDING THE PUNCTURE SITE ARE INDICATIVE OF CONTACT WITH A SHARP EXTERNAL OBJECT SUCH AS CALCIFICATION. IT WAS ALSO INDICATED ANOTHER MFR'S BALLOON PUMP'S OPACITY ALARM SOUNDED AND NO ACTIONS WERE TAKEN. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTIBUTE THIS EVENT TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 940 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLN CATH DSP CARDIAC ASSIST A DIV. OF BOSTON SCIENTIFIC CORP. NA 586657

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death