BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN NEEDLE ELECTRODE

    MDR report key: 1941346 · Received December 29, 2010

    Report

    Report Number
    3005099803-2010-05360
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GEI
    PMA / PMN Number
    K982556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN. HOWEVER, PATIENT OVER 18 YEARS OLD. 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 DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 EVALUATION FOUND THAT THE ARRAY, WHEN FULLY EXTENDED, MET THE OUTER DIAMETER MANUFACTURING SPECIFICATION. NO FUNCTIONAL ISSUES WERE IDENTIFIED AND THE ARRAY TINES WERE EVENLY SPACED AND UNDEFORMED. THEREFORE, THIS IS NOW A NON MDR-REPORTABLE EVENT. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES. FUNCTIONALLY, THE ARRAY WAS ABLE TO BE EXTENDED AND RETRACTED WITHOUT ISSUE. WHEN EXTENDED, THE ARRAY WAS UNDAMAGED AND PRESENTED WITH UNIFORM SPACING BETWEEN THE TINES. THE OUTER DIAMETER OF THE OPEN ARRAY WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED. 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 RENAL RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, THE DIAMETER OF THE ARRAY APPEARED TO BE APPROXIMATELY 4.0CM, NOT 3.5CM WHICH WAS THE EXPECTED SIZE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS LEVEEN NEEDLE ELECTRODE.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 STABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PHYSICIAN IDENTIFIED THE SIZE DISCREPANCY PRIOR TO PERFORMING THE ABLATION, BUT HAD NO CONCERNS ABOUT USING THE ELECTRODE IN THE PROCEDURE. THE ACCOUNT REPORTED THAT THE TARGET LESION WAS APPROXIMATELY 3.2CM AND LOCATED IN THE TOP RIGHT OF THE KIDNEY. AFTER USE, NO VISIBLE ISSUES WERE NOTED WITH THE ELECTRODE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A RENAL RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE DIAMETER OF THE ARRAY APPEARED TO BE APPROXIMATELY 4.0CM, NOT 3.5CM WHICH WAS THE EXPECTED SIZE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS LEVEEN NEEDLE ELECTRODE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN NEEDLE ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262020 12820081

    Patients

    Seq Age Sex Outcome Treatment
    1