BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN¿ COACCESS¿

    MDR report key: 2884061 · Received December 21, 2012

    Report

    Report Number
    3005099803-2012-06216
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT PATIENT WEIGHT IS UNKNOWN, BUT IT WAS REPORTED THAT THE PATIENT WAS OBESE. (B)(4) FOR THE REPORTED EVENT: FAILURE TO ACHIEVE ROLL-OFF. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE WAS USED DURING A HEPATIC RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE USER WAS UNABLE TO ACHIEVE ROLL-OFF WITH THE DEVICE; THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE. IT WAS REPORTED THAT THE RADIOFREQUENCY GENERATOR USED DURING THE PROCEDURE HAS BEEN USED SUCCESSFULLY SINCE THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN¿ COACCESS¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262220 0014456126

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR