BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBLE

    MDR report key: 2312375 · Received October 24, 2011

    Report

    Report Number
    1056436-2011-00060
    Event Type
    Other
    Date Received
    October 24, 2011
    Date of Event
    October 3, 2011
    Report Date
    October 20, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS THE OPINION OF MEDICAL AFFAIRS THAT THIS TYPE OF PRODUCT FAILURE COULD BE RELATED TO A DEFECTIVE PIECE OF METAL, A MANUFACTURING ISSUE, USER TECHNIQUE, OR ANATOMICAL CONSIDERATIONS. GIVEN THE PTS HISTORY OF PREVIOUS TREATMENT OF TISSUES IN THE AREA BY MULTIPLE INTERVENTIONS, IT WOULD BE EXPECTED TO BE COMPROMISED OF FIBROUS BANDS OF TISSUE. THE TUMOR WOULD ALSO BE EXPECTED TO CONTAIN REGIONS OF HARD FIBROUS TISSUE FROM THE PREVIOUS RADIATION AND THERMAL ABLATIONS. TRYING TO PIERCE THIS TISSUE WITH THE PROBE IS MOST LIKELY EXPLANATION FOR THE BENT AND MISSING TINE. LEAVING A SMALL FOREIGN BODY (TINE) IMBEDDED IN TISSUE IS NOT CONSIDERED DANGEROUS AND WOULD NOT BE EXPECTED TO LEAD TO SERIOUS HARM, PERMANENT INJURY, OR IMPAIRMENT OF NORMAL BODY FUNCTION.

    Description of Event or Problem · 1

    ONE RE-INTRODUCTION OF THE RF PROBE FOR THE 2ND ABLATION, DR. NOTED THE PROBE WAS DIFFICULT TO INTRODUCE DUE TO PRIOR RADIOTHERAPY AND ABLATION. AN ERROR MESSAGE "BAD DEVICE OR CONNECTION-TC3" WAS SEEN. ON SCANNING THE PATIENT IN CT, DR. SAW THAT WHAT APPEARED TO BE A TINE FROM THE PROBE STUCK IN THE TUMOUR. A SECOND PROBE WAS OPENED AND TREATMENT SUCCESSFULLY COMPLETED. THE TINE WAS LEFT IN THE PT. DEVICE NOT KEPT FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XLI ENHANCED SEM-FLEX, 25CM, FLEXIBLE RFA PROBE GEI ANGIODYNAMICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other