BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTO SHORT EXTRACTION CATHETER

    MDR report key: 1153360 · Received September 5, 2008

    Report

    Report Number
    2134812-2008-00008
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    September 5, 2008
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PRONTO SHORT DISTAL TIP SEPARATED FROM THE CATHETER DURING THE PROCEDURE, AND THE PATIENT REQUIRED SURGERY TO REMOVE THE TIP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRONTO SHORT EXTRACTION CATHETER DXE, EMBOLECTOMY CATHETER DXE VASCULAR SOLUTIONS, INC. 5030 542789

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention