BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET AVX

    MDR report key: 8636757 · Received May 23, 2019

    Report

    Report Number
    2134265-2019-05659
    Event Type
    Death
    Date Received
    May 23, 2019
    Date of Event
    April 24, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889045
    PMA / PMN Number
    K133629
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PATIENT EXPERIENCED CHEST PAIN AND LOSS OF CONSCIOUSNESS. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR USE IN A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT SWINGS IN AND OUT OF CONSCIOUSNESS, WAS OUT OF BREATH AND FELT TIRED; HOWEVER THE PATIENT'S HEART RATE REMAINED STABLE. WHEN BEING DISCHARGED, THE PATIENT COMPLAINED OF HAVING TO BURP, BUT COULD NOT. THE PATIENT EXPERIENCED PAIN IN THE CHEST AND WAS TAKEN TO THE EMERGENCY ROOM WHERE THE PATIENT CODED AND DIED. IT WAS FURTHER REPORTED THAT THE CASE WAS FOR A GRAFT OR FISTULA IN A HEMODIALYSIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PATIENT EXPERIENCED CHEST PAIN AND LOSS OF CONSCIOUSNESS. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR USE IN A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT SWINGS IN AND OUT OF CONSCIOUSNESS, WAS OUT OF BREATH AND FELT TIRED; HOWEVER THE PATIENT'S HEART RATE REMAINED STABLE. WHEN BEING DISCHARGED, THE PATIENT COMPLAINED OF HAVING TO BURP, BUT COULD NOT. THE PATIENT EXPERIENCED PAIN IN THE CHEST AND WAS TAKEN TO THE EMERGENCY ROOM WHERE THE PATIENT CODED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429647 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0023536296 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death