BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER

    MDR report key: 643579 · Received October 28, 2005

    Report

    Report Number
    2183460-2005-00013
    Event Type
    Injury
    Date Received
    October 28, 2005
    Date of Event
    September 28, 2005
    Report Date
    October 28, 2005
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH HX OF RECURRENT DVT, VENA CAVAL FILTER, PE WITH ANTICOAGULATION. TRANSFERRED FOR TX OF RECURRENT DEOCAVAL DVT WITH LYSIS X 24 PRIOR TO AJ TREATMENT PT WITH RENAL INSUFFICIENCY AT 2.1 ADMISSION & 1.7 P HYDRATION 240CC AJ WITH DVX CATHETER (CHANNEL CREATED) AND IMMEDIATE HEMOGLOBINURIA ART UPPER 10 NOW GRADUALLY TO 9. NO HD DONE ALTHOUGH HD CATHETER PLACED. PT RECEIVED NO PRE TX OF MUCOMEPT OR BICARB IV FLD. HYDRATED WILL P PROCEDURE WITH RENAL FOLLOWING PT CLOSELY. PHYSICIAN FELT THERE WERE NO OTHER OPTION FOR TX WITH PT AND CURRENTLY DVT RESOLVED WITH AJ & STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER DVX DXE POSSIS MEDICAL, INC. DVX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention