BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSTION PLUS 7.SFR 40CC INTRA AORTIC BALLOON CATHETER

    MDR report key: 11384879 · Received February 25, 2021

    Report

    Report Number
    MW5099641
    Event Type
    Death
    Date Received
    February 25, 2021
    Date of Event
    February 5, 2021
    Report Date
    February 12, 2021
    Manufacturer
    GETINGE / DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NSTEMI COMPLICATED BY VT ARREST. CORONARY ANGIOGRAM DEMONSTRATED SEVERE MULTIVESSEL DISEASE. IABP PLACED. ON (B)(6) 2021, PATIENT EXPERIENCED LABILE BLOOD PRESSURES AND AT 7 PM REQUIRED INCREASING VASOPRESSORS. ONSET OF AFIB WITH INCREASING ECTOPY (PAC'S, PVC'S. IABP BEGAN TO ALARM WITH MESSAGES: CHECK CATHETER POSITION" AND "AUTO R WAVE DEFLATION." CPR WAS INITIATED. AT END OF CPR, SMALL AMOUNT OF BLOOD NOTED IN HELIUM LINE. PATIENT IN PULSELESS VT DESPITE ON-GOING EFFORTS AND FAMILY CONSULTED. DECISION MADE TO TRANSITION TO COMFORT MEASURES ONLY AND RESUSCITATION DISCONTINUED. UPON REMOVAL OF CATHETER/BALLOON, SMALL HOLE IN BALLOON NOTED. THE PATIENT PRESENTED URGENTLY WITH NSTEMI, ELEVATION IN CARDIAC BIOMARKERS AND CONTINUING SYMPTOMS DESPITE AGGRESSIVE ANTI-ANGINAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273771 SENSTION PLUS 7.SFR 40CC INTRA AORTIC BALLOON CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP GETINGE / DATASCOPE CORP. MAQUET SENSATION P1 5649979

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death