BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET AVX

    MDR report key: 8636753 · Received May 23, 2019

    Report

    Report Number
    2134265-2019-05655
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    April 26, 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 THAT THE PATIENT EXPERIENCED BRADYCARDIA AND VENTRICULAR TACHYCARDIA DURING THE PROCEDURE. 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'S HEART RATE WAS IN THE 80'S THEN IT DROPPED TO THE 30'S. THERE WAS A SIGNIFICANT AMOUNT OF PAIN IN THE CHEST/LUNGS AND THE PROCEDURE HAD TO BE STOPPED. ALMOST IMMEDIATELY AFTER THE USE OF THE ANGIOJET, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. AFTER THE PROCEDURE, THE PATIENT FELT THE NEED TO VOMIT. 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 THAT THE PATIENT EXPERIENCED BRADYCARDIA AND VENTRICULAR TACHYCARDIA DURING THE PROCEDURE. 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'S HEART RATE WAS IN THE 80'S THEN IT DROPPED TO THE 30'S. THERE WAS A SIGNIFICANT AMOUNT OF PAIN IN THE CHEST/LUNGS AND THE PROCEDURE HAD TO BE STOPPED. ALMOST IMMEDIATELY AFTER THE USE OF THE ANGIOJET, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. AFTER THE PROCEDURE, THE PATIENT FELT THE NEED TO VOMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429644 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0023537502 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other