BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COACCESS NEEDLE ELECTRODE

    MDR report key: 1071619 · Received July 9, 2008

    Report

    Report Number
    3005099803-2008-01093
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE DID NOT REVEAL ANY NOTABLE DEFECTS WITH EITHER THE ELECTRODE OR THE INTRODUCER. NOMINAL DEPLOYMENT AND RETRACTION OF THE ELECTRODE ARRAY WAS CONFIRMED; UNIFORM UMBRELLA SHAPE OF THE DEPLOYED TINES WAS ALSO CONFIRMED. ELECTRICAL CONTINUITY OF THE ELECTRODE ARRAY WAS VERIFIED. A REVIEW OF THE CUSTOMER SHIPMENT HISTORY IDENTIFIED THREE LOTS SHIPPED PRIOR TO THE REPORTED EVENT. (LOTS: 11584380, 11495595 & 11430580). REVIEW OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY OTHER COMPLAINTS RECORDED FOR LOTS 11495595 AND 11430580; ONE ADDITIONAL COMPLAINT WAS RECORDED FOR LOT 11584380 ( A DIFFERENT MALFUNCTION). REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR EACH OF THE THREE LOTS WAS PERFORMED; NO ANOMALIES WERE NOTED IN ANY OF THE DHRS. THE JUNE 2008 15-MONTH RF PROBE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO REPORTED MALFUNCTIONS OCCURRING DURING THE SAME PROCEDURE. REFER TO MFR REPORT #3005099803-2008-01107 FOR DETAILS REGARDING THE SECOND REPORT MALFUNCTION. IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RF ABLATION PROCEDURE WAS PERFORMED USING A CO-ACCESS NEEDLE ELECTRODE DEVICE. ACCORDING TO THE COMPLAINANT, RF ABLATION WAS ATTEMPTED AT S8 AND S4 OF THE LIVER UNDER GENERAL ANESTHESIA. IT WAS REPORTED THAT THE FIRST ABLATION AT S8 WAS ATTEMPTED WITH FULL TINE ARRAY DEPLOYMENT, AT RF POWER FROM 60 WATTS TO 130 WATTS; HOWEVER, NO INDICATION OF ABLATION WAS SEEN UNDER ECHO. ABLATION WAS ALSO ATTEMPTED AT S4 FROM 60 WATTS TO 180 WATTS FOR TEN MINUTES. HOWEVER, THERE WAS STILL NO INDICATION OF ABLATION SEEN. THE PHYSICIAN NOTED THE PATIENT'S TEMPERATURE WENT UP, FROM 36.6 TO 38.1 DEGREES CENTIGRADE, AND THOUGHT THAT THE FEVER WAS RELATED TO THE ABLATIONS AND DECIDED TO CANCEL THE PROCEDURE. WHEN THE NEEDLE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT NO RESIDUE WAS SEEN AT THE DISTAL END OF THE NEEDLE. AT THE CONCLUSION OF THE PROCEDURE, THE COMPLAINANT INDICATED THAT ONE OF THE FOUR PATIENT GROUND PADS WAS DISCOLORED; IT WAS UNKNOWN IF THE GROUND PAD WAS DISCOLORED PRIOR TO USE IN THIS PROCEDURE. NO BURN OF THE PATIENT'S SKIN WAS OBSERVED. ACCORDING TO THE COMPLAINANT, THE PATIENT'S TEMPERATURE RETURNED TO "NORMAL" DURING THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COACCESS NEEDLE ELECTRODE GEI BOSTON SCIENTIFIC CORPORATION M001262220 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other