BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPEEDIOR 100 ANGIOJET CATHETER

    MDR report key: 296939 · Received September 19, 2000

    Report

    Report Number
    2183460-2000-00014
    Event Type
    Injury
    Date Received
    September 19, 2000
    Date of Event
    August 17, 2000
    Report Date
    September 18, 2000
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED TACHYCARDIA WHEN ANGIOJET XPEEDIOR 100 CATHETER WAS USED IN DIALYSIS GRAFT OF LEFT UPPER ARM. SCRUB NURSE CONCERNED BUT THE MD (DIR OF IR) WAS NOT. PT RECORD AND STRIP WERE SENT TO PMI. PER PT, WHEN AJ IN PROGRESS, IT "FEELS LIKE WHEN MY BP GOES DOWN IN DIALYSIS". WHEN AJ WAS ON HEART RATE INCREASED TO 150-190'S, WHEN AJ WAS OFF HEART RATE RETURNED TO 70-80'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPEEDIOR 100 ANGIOJET CATHETER THROMBECTOMY CATHETER DXE POSSIS MEDICAL, INC. XF100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention VERSED, FENTOMYL.