BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN? SUPERSLIM?

    MDR report key: 3954977 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04397
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED ONE COACCESS ELECTRODE AND CORD WERE RETURNED WITH RESIDUE PRESENT ON THE DEVICE INDICATING HANDLING/USE. A VISUAL EXAMINATION OF THE DEVICE FOUND THE TINES TO BE FULLY RETRACTED. A FUNCTIONAL EVALUATION WAS PERFORMED BY EXTENDING THE ARRAY WITH SOME RESISTANCE NOTED DUE TO HEAVY RESIDUE INSIDE THE DEVICE. THE TINES WERE FOUND TO BE PROPERLY FORMED AND EVENLY SPACED. A SECOND FUNCTIONAL EVALUATION WAS PERFORMED BY MEASURING THE CONTINUITY AND THE ELECTRODE WAS ABLE TO CONDUCT CURRENT INDICATING PROPER CONNECTIVITY AT 0.56 OHMS. THE CORD WAS THEN TESTED AND WAS MEASURED TO BE 0.23 OHMS. THE CORD WAS THEN ATTACHED TO THE ELECTRODE AND THE CONDUCTIVITY OF THE COMBINATION WAS MEASURED TO BE 0.68 OHMS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2014-04750. IT WAS REPORTED THAT ROLL-OFF TOOK LONGER THAN ANTICIPATED. THE PATIENT WAS UNDERGOING RADIOFREQUENCY ABLATION (RFA) OF THE LIVER UTILIZING A 2.0/17/15 LEVEEN SUPERSLIM ELECTRODE AND A RF3000 RADIOFREQUENCY GENERATOR. AFTER ABLATING THE LESION WITH THIS DEVICE FOR 5MIN 30SEC, THE IMPEDANCE SHOWED THE HIGH VALUE, BUT THE DEVICE FAILED TO ROLL OFF. AN ERROR CODE WAS DISPLAYED, BUT CANNOT BE RECALLED BY THE USER. IT WAS FURTHER NOTED THAT THE PHYSICIAN MOVED THE NEEDLE DURING USE RESULTING IN A RISE AND FALL OF THE IMPEDANCE VALUE AND A CHANGE IN THE OUTPUT. ROLL-OFF WAS EVENTUALLY ACHIEVED AND THE USER INDICATED THIS LIKELY OCCURRED DUE TO MOVING THE TIP OF THE NEEDLE WHILE ABLATING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2014-04750. IT WAS REPORTED THAT ROLL-OFF TOOK LONGER THAN ANTICIPATED. THE PATIENT WAS UNDERGOING RADIOFREQUENCY ABLATION (RFA) OF THE LIVER UTILIZING A 2.0/17/15 LEVEEN SUPERSLIM ELECTRODE AND A RF3000 RADIOFREQUENCY GENERATOR. AFTER ABLATING THE LESION WITH THIS DEVICE FOR 5MIN 30SEC, THE IMPEDANCE SHOWED THE HIGH VALUE, BUT THE DEVICE FAILED TO ROLL OFF. AN ERROR CODE WAS DISPLAYED, BUT CANNOT BE RECALLED BY THE USER. IT WAS FURTHER NOTED THAT THE PHYSICIAN MOVED THE NEEDLE DURING USE RESULTING IN A RISE AND FALL OF THE IMPEDANCE VALUE AND A CHANGE IN THE OUTPUT. ROLL-OFF WAS EVENTUALLY ACHIEVED AND THE USER INDICATED THIS LIKELY OCCURRED DUE TO MOVING THE TIP OF THE NEEDLE WHILE ABLATING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434352 LEVEEN? SUPERSLIM? ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262260

    Patients

    Seq Age Sex Outcome Treatment
    1