BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARBURST¿ ELECTRODE

    MDR report key: 9192641 · Received October 15, 2019

    Report

    Report Number
    1317056-2019-00138
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    August 10, 2019
    Report Date
    December 5, 2019
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    UDI-DI
    H7877001019301
    PMA / PMN Number
    K010060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED FOR EVALUATION WAS A STARBURST XL 10CM PROBE. A VISUAL REVIEW OF THE RETURNED SAMPLE NOTED NO OBVIOUS DEFECTS. THE DEVICE WAS CONNECTED TO A 1500X RF GENERATOR. THE UNIT GAVE THE MESSAGE OF "BAD DEVICE OR CONNECTION / TC5[?]". WINDOW DISPLAYS 1, 2, 3 AND 4 READ AMBIENT TEMPERATURES AND WERE OBSERVED TO RISE WHEN EACH TINE WAS GRASPED WITH GLOVED FINGERS. WINDOW #5 SHOWED "OP". THE REPORTED COMPLAINT DESCRIPTION OF THE TEMPERATURE WINDOW OF TC5 SHOWING OP IS CONFIRMED. ALTHOUGH THE COMPLAINT IS CONFIRMED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. DEVICE WAS DISASSEMBLED AND INSPECTED TO FIND THE RED TC WIRE WAS BROKEN. TC WIRES ARE 40 AWG WIRES AND ARE FRAGILE. IF ANY KIND OF WEAKNESS/JOINT IN A TC WIRE IS CREATED, IT TAKES MINIMAL MOVEMENT TO SEVER THE TC WIRE. A DEVICE HISTORY RECORDS SEARCH REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. LABELING REVIEW: THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE USER WITH THIS CATALOG NUMBER, CONTAINS THE FOLLOWING STATEMENTS: "VERIFY THAT EACH OF THE DEVICE TEMPERATURE NEEDLES IS FUNCTIONING BY HOLDING THE TEMPERATURE NEEDLES BETWEEN YOUR STERILE, GLOVED FINGERS. THE TEMPERATURE READINGS ON THE RF GENERATOR SHOULD INCREASE WITHIN 30 SECONDS. IF THEY DO NOT, CHECK CONNECTIONS AND TRY AGAIN." A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. COMPLAINT REFERENCE # (B)(4).

    Description of Event or Problem · 1

    AS REPORTED: DURING AN RFA PROCEDURE USING A STARBURST RFA PROBE, "OP" SHOWED UP ON THE FIFTH TEMPERATURE WINDOW AND COULDN'T START ABLATION. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. AS THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS UNNECESSARILY SEDATED, THIS EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT. IT WAS INDICATED THE PATIENT DID NOT SUFFER ANY HARM OR INJURY DUE TO THE EVENT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988069 STARBURST¿ ELECTRODE ELECTROSURGICAL PROBE,, GEI ANGIODYNAMICS 5436753 H7877001019301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other