BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRA IAB CATHETER

    MDR report key: 9503852 · Received December 19, 2019

    Report

    Report Number
    MW5091779
    Event Type
    Death
    Date Received
    December 19, 2019
    Date of Event
    August 14, 2019
    Report Date
    November 15, 2019
    Manufacturer
    INSIGHTRA MEDICAL, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AFTER CABG SURGERY, DR USED ECMO AND IABP TO SUPPORT PT AT (B)(6) 2019. THEY FOUND THE CS300 ALARM AND STOP PUMPING. THEY TRIED TO RESTART PUMPING AND FOUND BLOOD GO IN TO CATHETER AND STOP PUMPING. DR ALREADY TOOK OUT THE CATHETER FROM THE PT. AFTER CORONARY ARTERY BYPASS GRAFTING (CABG) SURGERY, THE PHYSICIAN USED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND IABP TO SUPPORT THE PT ON (B)(6) 2019. DURING USE OF THE IABP, AN ALARM WAS TRIGGERED AND STOPPED PUMPING. THEY TRIED TO RESTART PUMPING AND FOUND BLOOD GOING INTO CATHETER AND STOPPED THE PROCEDURE. THE PHYSICIAN REMOVED THE CATHETER FROM THE PT AND INJECTED SALINE INTO THE DEVICE WHICH REVEALED A LEAKAGE (HOLE) AT THE END OF THE BALLOON. THIS PT WAS STILL TREATED USING ECMO, BUT ANOTHER IABP CATHETER TO SUPPORT PT WITH NO ISSUES. THE PT DIED ON (B)(6) 2019. INSIGHTRA WAS NOTIFIED OF PT'S DEATH ON OCTOBER 29, 2019. PT (B)(6) Y/O / MALE - CONSOLE MAKE AND MODEL: CS300. PT VASCULAR DISEASE: CALCIFICATION - CATHETER BEING USED AFTER CABG SURGERY. INCIDENT OCCURRED AFTER 3 DAYS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286707 ULTRA IAB CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP INSIGHTRA MEDICAL, INC. IMU7F-35CC 11271702

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| H