BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 1931761 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05315
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ELECTRODE WAS RECEIVED WITH THE ARRAY FULLY EXTENDED. A VISUAL EXAMINATION REVEALED THAT THE ARRAY WAS SLIGHTLY TILTED AND THE TINES WERE UNEVENLY SPACED AND DEFORMED. A FUNCTIONAL EVALUATION WAS PERFORMED BY EXTENDING AND RETRACTING THE ARRAY. WHEN PARTIALLY RETRACTED, TWO OF THE WIRES CROSSED. THE TWO CROSSED WIRES THEN RELEASED WHEN RE-EXTENDED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE ARRAY WAS NOT EXTENDING PROPERLY. THE EVALUATION REVEALED THAT THE TINES WERE UNEVENLY SPACED AND DEFORMED. HOWEVER, THE ELECTRODE WAS RECEIVED WITH THE ARRAY FULLY EXTENDED, SO THE DAMAGE MAY HAVE OCCURRED DURING SHIPPING. SINCE THE SPECIFIC CAUSE OF THE FAILURE CANNOT BE IDENTIFIED, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A PERITONEAL AND LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AN ABLATION WAS BEING PERFORMED IN ORDER TO DE-BULK TWO LARGE TUMORS, THE FIRST BEING OVER 5CM AND THE SECOND APPROXIMATELY 8CM. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO POSITION THE 5CM ELECTRODE AND AGAIN WHILE ATTEMPTING TO EXTEND THE ARRAY. ADDITIONALLY, WHEN EXTENDED, THE PHYSICIAN FELT THAT THE TINES HAD NOT DEPLOYED IN AN EVEN MANNER. THE ELECTRODE WAS THEN WITHDRAWN, BUT THE TINES FAILED TO FULLY RETRACT. AS A PREVENTATIVE MEASURE AGAINST A BLEED, THE PHYSICIAN APPLIED CAUTERY WHILE REMOVING THE ELECTRODE. A 4CM LEVEEN COACCESS ELECTRODE SYSTEM WAS THEN ADVANCED AND DEPLOYED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A PERITONEAL AND LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, AN ABLATION WAS BEING PERFORMED IN ORDER TO DE-BULK TWO LARGE TUMORS, THE FIRST BEING OVER 5CM AND THE SECOND APPROXIMATELY 8CM. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO POSITION THE 5CM ELECTRODE AND AGAIN WHILE ATTEMPTING TO EXTEND THE ARRAY. ADDITIONALLY, WHEN EXTENDED, THE PHYSICIAN FELT THAT THE TINES HAD NOT DEPLOYED IN AN EVEN MANNER. THE ELECTRODE WAS THEN WITHDRAWN, BUT THE TINES FAILED TO FULLY RETRACT. AS A PREVENTATIVE MEASURE AGAINST A BLEED, THE PHYSICIAN APPLIED CAUTERY WHILE REMOVING THE ELECTRODE. A 4CM LEVEEN COACCESS ELECTRODE SYSTEM WAS THEN ADVANCED AND DEPLOYED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262160 13071900

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR