BEUDAMED
    FDA Adverse Event Death Summary report: N

    DATASCOPE FIDELITY

    MDR report key: 1021511 · Received March 31, 2008

    Report

    Report Number
    MW5006047
    Event Type
    Death
    Date Received
    March 31, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 28, 2008
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2008 - INSERTION OF INTRA AORTIC BALLOON PUMP VIA RIGHT FEMORAL ARTERY VIA 8.5 FRENCH SHEATH. THE SAM DAY, CABG. FOUR DAYS LATER, INTRA AORTIC BALLOON CATHETER REMOVED- ? SHEARING OF DISTAL TIP- PT TO OR FOR EXPLORATION AND REMOVAL. DEVICE REMOVED WAS LABELED 14.0 LR AND COOK, TUBING LABELED DATASCOPE-FIDELITY 8 FR #18470668-END OF BALLOON APPEARS TORN AND FRAGMENTED 5.5 CM FROM FRAGMENTED END IS ADD'L FRAGMENTATION 2.7 WITH INDURATED DARK REDDISH BROWN TO PURPLISH MATERIAL. PER MD: DRIVE LINE OF INTRA AORTIC BALLOON PUMP HAD SHOWED SIGNS OF TRACKING, PUMP INFLATION HAD BECOME ERRATIC. PUMP DEEMED DYSFUNCTIONAL-TO BE REMOVED. ATTEMPTED DEFLATION OF PUMP AND NEGATIVE PRESSURE ON THE DRIVE LINE AS THE SHEATH WAS TAKEN OUT OF THE PUNCTURE SITE FIRST THEN THE CATHETER. THE CATHETER CAME OUT WITHOUT THE DISTAL PART OF IT THAT CONTAINED THE BALLOON. IT SNAPPED SUDDENLY AND THE BALLOON PART EMBOLIZED INTO THE FEMORAL ARTERY. PT TAKEN TO OR FOR EXPLORATION AND REMOVAL. BALLOON EXTRACTED THRU LEFT GROIN AND INABILITY IN RIGHT GROIN. THE EXTRACTED BALLOON SHOWED EVIDENCE OF STRUCTURAL DETERIORATION, WITH DEVELOPMENT OF A NODULE IN MID PART OF THE SHAFT OF THE BALLOON SEGMENT-LOOKED PER SURGEON LIKE A BLACK PIECE OF MELTED PLASTIC OR POLYMER MATERIAL. PT DEVELOPED V-TACH-CARDIAC ARREST-DEATH. COMPLETE EXTRACTION OF BALLOON ACHIEVED AFTER DEATH. DATES OF USE: FIVE DAYS IN 2008. DIAGNOSIS OR REASON FOR USE: CONGESTIVE HEART FAILURE, LOW BLOOD PRESSURE, ACUTE REQUIRED CORONARY ARTERY BYPASS GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE FIDELITY INTRA AORTIC BALLOON 8 FRENCH 34CC DSP DATASCOPE CORP 0684-00-0328 1847

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death