BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN COACCESS ELECTRODE SYSTEM

    MDR report key: 1009263 · Received March 7, 2008

    Report

    Report Number
    3005099803-2008-00258
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    December 11, 2007
    Report Date
    February 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOS
    PMA / PMN Number
    K012315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THIS LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADD'L COMPLAINTS FOR LOT NUMBER 8233906. THE DEC 2007 15-MONTH RF PROBES PROD FAMILY COMPLAINT TREND REPORT WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. THE LEVEEN COACCESS ELECTRODE SYS WAS RECEIVED FOR EVAL. RESIDUE WAS PRESENT ON THE DEVICE TO INDICATE USE. THE INSULATION WAS FOUND TO BE DAMAGED UPON RETURN. A VISUAL EVAL FOUND THAT THE INSULATION ON THE INTRODUCER WAS TORN AND SPLIT OPEN IN MULTIPLE PLACES. THE EVAL ALSO FOUND THAT THE NEEDLE CANNULA WAS STUCK INSIDE THE INTRODUCER. THE INTRODUCER COULD NOT BE REMOVED FROM THE NEEDLE CANNULA EVEN WHEN FORCE WAS APPLIED. THIS CUSTOMER'S REPORTED COMPLAINT CONDITION WAS CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THE EVENT IS THAT WHEN THE NEEDLE WAS REMOVED FROM THE INTRODUCER, RESIDUE WAS PULLED UP INSIDE THE INTRODUCER. WHEN AN ATTEMPT WAS MADE TO REINSERT THE NEEDLE INTO THE INTRODUCER, THE RESIDUE CAUSED INTERFERENCE BETWEEN THE NEEDLE AND INTRODUCER. THIS INTERFERENCE DID NOT ALLOW THE INTRODUCER TO BE REMOVED DURING THE EVAL.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A THERAPUETIC RADIOFREQUENCY ABLATION (RFA) PROCEDURE WAS ABOUT TO BE PERFORMED ON A PT. THE COMPLAINANT REPORTED THAT WHEN THE CLINICIANS BEGAN TO INSERT THE LEVEEN COACCESS ELECTRODE NEEDLE INTO THE INTRODUCER, SOME RESISTANCE WAS FELT. BECAUSE THE RESISTANCE WAS FELT TO BE MINOR, THE PHYSICIAN CONTINUED INSERTING THE DEVICE. AFTER THE DEVICE WAS INTRODUCED INTO THE PT'S LIVER, THE NEEDLE WAS EXCHANGED. IN AN EFFORT TO EXAMINE THE TINES INSIDE THE PT'S ANATOMY, THE PHYSICIAN PARTIALLY DEPLOYED THE LEVEEN COACCESS TINES. AT THIS POINT, THE PT WAS REPORTED TO HAVE "FELT BADLY" AND THE PHYSICIAN IMMEDIATELY REMOVED THE NEEDLE FROM THE PT. AFTER CALMING THE PT, THE PHYSICIAN AGAIN INSERTED THE NEEDLE INTO THE INTRODUCER, HOWEVER, SEVERE RESISTANCE WAS FELT. DUE TO THE RESISTANCE, THE DEVICE WAS REMOVED FROM THE PT. WHILE THE DEVICE WAS OUTSIDE THE PT'S ANATOMY, THE PHYSICIAN INSERTED THE NEEDLE INTO THE INTRODUCER, BUT AGAIN SEVERE RESISTANCE WAS FELT. THE PROCEDURE WAS NOT COMPLETED AT THAT TIME DUE TO THIS EVENT. THE COMPLAINANT REPORTED THAT THERE WAS NO ADVERSE AFFECT ON THE PT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN COACCESS ELECTRODE SYSTEM JOS BOSTON SCIENTIFIC CORPORATION M001262230 8233906

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK