BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3113620 · Received May 9, 2013

    Report

    Report Number
    1056436-2013-00024
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    K992693
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GRIEVANCE HAS BEEN FILED BY THE PT AGAINST THE HOSPITAL. AS THE LOT NUMBER OF THE DEVICE WAS NOT REPORTED. A SHIP HISTORY REPORT (SHR) WAS GENERATED IN ORDER TO ASCERTAIN THE LAST THREE LOTS OF THE REPORTED CATALOG NUMBER (700-103909) SHIPPED TO THE REPORTING CUSTOMER IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE LOT NUMBERS (586544 AND 586968) OBTAINED THROUGH THE SHR FOR THE PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. NOTHING WAS FOUND IN THE SHIP HISTORY REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. AS THE REPORTED COMPLAINT SAMPLE WAS RETAINED BY THE USER AND NOT RETURNED. ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVAL. THE CUSTOMER'S COMPLAINT DESCRIPTION CANNOT BE CONFIRMED. A REVIEW OF THE ORDERING HISTORY FOR THE COMPLAINANT (B)(6) NOTED THAT THEY HAVE A HISTORY OF ORDERING THE FOLLOWING RF PROBES; 700-102845, 700-103909 AND 700-102615. OF THE THREE; THE COMPLAINANT ORDERS 700-102845 MORE REGULARLY, WITH THE LAST ORDER BEING PLACED ON (B)(4) 2012 (DELIVERY NUMBER (B)(4)). ON (B)(4) 2013, CUSTOMER ORDERED 700-102615 VIA GHX (B)(4). THE LAST ORDER FOR 700-102615 WAS PLACED ON (B)(4) 2009 (DELIVERY NUMBER (B)(4)). THIS CATALOG NUMBER IS NO LONGER AVAILABLE FOR SALE WITHIN THE UNITED STATES. PER A NOTICE IN SAP, CUSTOMER SERVICE CHANGED THE ORDER TO A 700-103909. BOTH DEVICES ARE 25CM SEMIFLEX STARBURST. THE ONLY DIFFERENCE IS THAT THE 700-103909 HAS A PRE-ATTACHED MAIN CABLE AND 700-102615 DOES NOT. BOTH DEVICES ARE NON-INFUSED. NO ALLEGED DEVICE MALFUNCTION WAS NOTED. THE INSTRUCTION FOR USE (160-104121, REV.05), WHICH IS SUPPLIED TO THE USER WITH THIS CATALOG UMBER (700-103909) WAS REVIEWED AND NOTHING WAS FOUND IN THE INSTRUCTIONS FOR USE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE PROCEDURE WAS COMPLETED WITH THIS SAME DEVICE. NO FURTHER CORRECTIONS ARE REQUIRED BASED ON THE RELATIVE LOW FREQUENCY OF THIS FAILURE MODE VS. RFA SALES VOLUME, ADEQUATE WARNINGS IN THE INSTRUCTIONS FOR USE AND PROCESS CONTROLS TO DETECT THIS TYPE OF FAILURE. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2013 BY THE USER, HOSPITAL CLAIMS THEY WERE INSTRUCTED BY CS TO ORDER 700-103909 IN PLACE OF THE 700-102845 DUE TO THE 700-102845 NO LONGER BEING AVAILABLE; DOC USED THE 700-103909 PROBE FOR A RENAL RFA WHICH TOOK LONGER THAN THEY EXPECTED RESULTING IN THE PT CODING. THE PT DID REQUIRE ADDITIONAL ATTENTION BUT IS HOME NOW WITH NO LONG TERM COMPLICATIONS AS A RESULT OF THE PROCEDURE. A GRIEVANCE HAS BEEN FILED BY THE PT AGAINST THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204700 STARBURST SEMI-FLEX 3-5CM, 25CM LENGTH, FLEXIBLE RADIO FREQUENCY ABLATION PROBES GEI ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention