BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET AVX

    MDR report key: 8636756 · Received May 23, 2019

    Report

    Report Number
    2134265-2019-05653
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    April 23, 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 CHEST PAIN DURING THE PROCEDURE. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. THERE WAS A SIGNIFICANT AMOUNT OF PAIN AND THE PROCEDURE HAD TO BE STOPPED. 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 CHEST PAIN DURING THE PROCEDURE. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. THERE WAS A SIGNIFICANT AMOUNT OF PAIN AND THE PROCEDURE HAD TO BE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429643 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0023536296 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1 Other