BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET SOLENT PROXI

    MDR report key: 8116270 · Received November 29, 2018

    Report

    Report Number
    2134265-2018-63268
    Event Type
    Death
    Date Received
    November 29, 2018
    Date of Event
    November 13, 2018
    Report Date
    November 29, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    PMA / PMN Number
    K101406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED POST PROCEDURE. A SOLENT PROXI CATHETER AND A 2CM PERIPHERAL CUTTING BALLOON (PCB) WAS SELECTED FOR USE FOR AN ARTERIOVENOUS GRAFT THROMBECTOMY PROCEDURE IN THE LEFT ARM. THE TARGET LESION WAS STENOSED WITH A CLOT. THE SOLENT PROXI CATHETER WAS USED TO REMOVE THE CLOT. THE PHYSICIAN THEN USED THE PCB TO BALLOON THE GRAFT. THE ANGIOJET CATHETER WAS USED AGAIN. THE PHYSICIAN PERFORMED BALLOONING AGAIN AND WAS CONTINUING THE ANGIOPLASTY WHEN THE PATIENT BEGAN TO CODE. THE PROCEDURE WAS NOT COMPLETED. THE TOTAL AMOUNT ASPIRATED WITH ANGIOJET DURING THE PROCEDURE WAS 425CC. THERE WERE NO DEVICE ISSUES OR DEFECTS NOTED DURING THE PROCEDURE. THE PATIENT COMPLICATIONS WERE A MASSIVE PULMONARY EMBOLISM. THE PATIENT DIED. THE OFFICIAL CAUSE OF DEATH WAS UNKNOWN. THE PHYSICIAN DID NOT THINK THAT THE TWO DEVICES CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955664 ANGIOJET SOLENT PROXI CATHETER, CONTINUOUS FLUSH DXE BOSTON SCIENTIFIC CORPORATION 45032

    Patients

    Seq Age Sex Outcome Treatment
    1 Death