BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARBURST SEMI-FLEX, 25CM

    MDR report key: 3905527 · Received May 28, 2014

    Report

    Report Number
    1056436-2014-00032
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K992693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFO WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014 BY THE INTERNATIONAL DISTRIBUTOR, "THE FRONT PART OF THE STARBURST SEMIFLEX DEVICE BRAKES SHORT AFTER THE TRANCISION (TRANSITION) OF STIFF TO SEMIFLEXIBLE PART. THE PHYSICIAN COULD BRING BOTH PARTS OUT OF THE PT AND FINISH THE TREATMENT WITH A OTHER PROBE". NO HARM OR INJURY WERE REPORTED TO THE PT DUE TO THIS PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314971 STARBURST SEMI-FLEX, 25CM RFA PROBE GEI ANGIODYNAMICS, INC. 599658

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other