BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOJET® ULTRA PE

    MDR report key: 6912050 · Received October 3, 2017

    Report

    Report Number
    2134265-2017-09617
    Event Type
    Death
    Date Received
    October 3, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 11, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED POST-PROCEDURE. AN ANGIOJET® ULTRA PE CATHETER WAS USED FOR A PHARMOMECHANICAL THROMBECTOMY TREATMENT PROCEDURE OF A PULMONARY EMBOLUS. DURING THE PROCEDURE THE CATHETER WAS NOTED TO BE LEAKING INTO THE CONSOLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS DURING THE PROCEDURE; HOWEVER IT WAS REPORTED THAT THE PATIENT IS NOW DECEASED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN ABLE TO BE OBTAINED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691425 ANGIOJET® ULTRA PE CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 107171-003 19242430

    Patients

    Seq Age Sex Outcome Treatment
    1 Death