BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST SEMI-FLEX 3-5CM, 25CM LENGTH, FLEXIB

    MDR report key: 2396618 · Received December 28, 2011

    Report

    Report Number
    1056436-2011-00079
    Event Type
    Other
    Date Received
    December 28, 2011
    Date of Event
    December 21, 2011
    Report Date
    December 27, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DOCTOR TREATED A (B)(6) FEMALE PATIENT THAT PRESENTED WITH A OSTEOID OSTEOMA LOCATED IN THE MEDIAL SECTION OF THE RIGHT TIBULA. THE SKIN WAS RAISED AT THE LOCATION OF THE OSTEOID. THE DEPTH OF THE TIP OF THE RFA PROBE WAS 2CM. THE STARBURST SEMI FLEX PART NUMBER 700-103909 LOT NUMBER: 54654, AND STARBURST ACCESS SYSTEM PART NUMBER 700-102331 LOT NUMBER: B1QR WERE USED DURING THE CASE. ACCESS (UNDER CT GUIDANCE) WAS INITIALLY ATTEMPTED WITH THE 11CM STARBURST ACCESS SYSTEM. DOCTOR HAD DIFFICULTY PENETRATING THE TIBULA BY ROTATING THE ACCESS SYSTEM. DOCTOR EMPLOYED A MALLET ON-TOP OF THE ACCESS SYSTEM IN AN ATTEMPT TO ACCESS THE NIDUS, UNSUCCESSFULLY. AN ORTHO DRILL WAS FINALLY USED TO OBTAIN ACCESS TO THE NIDUS. THE STARBURST ACCESS SYSTEM WAS REINTRODUCED INTO THE CHANNEL. THE STARBURST ACCESS SYSTEM WAS REINTRODUCED INTO THE CHANNEL. THE STARBURST XL WAS INSERTED INTO THE ACCESS SYSTEM, AND VISUAL CONFIRMATION OF THE TIP OF THE XL PROBE WAS CONFIRMED TO BE IN THE NIDUS. THE DISPERSION PADS WERE CONNECTED TO THE SYSTEM AND REGISTERED 30 ON BOTH WINDOW A AND B. THE PROBE WAS CONNECTED TO THE GENERATOR. THE TEMPERATURE WAS SET TO 100. POWER WAS CONFIRMED AT 150 WATTS. TIME WAS SET TO 6 MINUTES. THE RF BUTTON WAS SELECTED." HEATING TO TARGET TEMPERATURE " WAS DISPLAYED IN THE DISPLAY WINDOW. "EFFICIENCY" MEASURED AT 1. APPROXIMATELY 30 SECONDS INTO THE DISPLAY WINDOW DISPLAYED "BAD CONNECTION" AND THE GENERATOR TERMINATED TREATMENT, AND STARTED COOLING DOWN. THE DOCTOR EXAMINED THE TIP OF THE RF PROBE AND DETERMINED THAT THE CENTER TINE OF THE PROBE WAS INTACT. SALINE WAS INTRODUCED VIA THE LURE CAP ON THE RFA PROBE. TREATMENT WAS RESUMED UNTIL THE DOCTOR NOTICED A DISCOLORATION OF THE SKIN AROUND THE INSERTION SITE OF THE ACCESS SYSTEM. THE SHAFT OF THE ACCESS SYSTEM WAS NOT HOT. THE DOCTOR INDICATED THAT ONLY THE SKIN NEAR THE ACCESS SITE WAS "HOT". PROCEDURE WAS STOPPED AT ONE MINUTE WHEN THE DOCTOR NOTICED THE DISCOLORATION OF THE SKIN AROUND THE ACCESS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST SEMI-FLEX 3-5CM, 25CM LENGTH, FLEXIB RFA PROBE GEI ANGIODYNAMICS NA 549654

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other