BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWER FLEX CORDIS 8MM X 4CM

    MDR report key: 347151 · Received August 7, 2001

    Report

    Report Number
    347151
    Event Type
    Injury
    Date Received
    August 7, 2001
    Date of Event
    July 27, 2001
    Report Date
    August 6, 2001
    Manufacturer
    CORDIS J/J
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PERCUTANEOUS TRANSLUMINAL ANGIOGRAPH (PTA) OF THE RIGHT ARM FISTULA THE BALLOON RUPTURED WITHIN THE LUMEN AND SEPARATED. THE BALLOON FRAGMENT DISLODGED. TO PREVENT FURTHER DISLODGEMENT A FOGARTY CATHETER WAS PLACED. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE FRAGMENT FROM THE ARTERIO-VENOUS FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35622 POWER FLEX CORDIS 8MM X 4CM ENDOVASCULAR FOR PTA BALLOON LIT CORDIS J/J * S0301093

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R