BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN¿ SUPERSLIM¿

    MDR report key: 3030256 · Received April 2, 2013

    Report

    Report Number
    3005099803-2013-01952
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    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

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE ARRAY RETRACTED, AND THE CANNULA WAS OBSERVED TO BE SLIGHTLY BENT. THE INSULATION WAS SCRATCHED AT MULTIPLE LOCATIONS ALONG THE WORKING LENGTH, AND NICKS WERE FOUND IN THE INSULATION AT 10.5CM, 11.5CM, AND 11.75CM FROM THE DISTAL END. THE COMPLAINT WAS CONFIRMED; THE INSULATION WAS DAMAGED. PER THE DIRECTIONS FOR USE (DFU) SUPPLIED WITH THIS DEVICE, "IF A NEEDLE GUIDE IS USED, SUCH AS WITH THE LEVEEN SUPERSLIM NEEDLE ELECTRODE, NOTE THAT NEEDLE GUIDES MAY HAVE SHARP EDGES THAT CAN CAUSE DAMAGE TO OR REMOVAL OF PORTIONS OF THE INSULATION ON THE ELECTRODE." IT IS LIKELY THAT THE INSULATION WAS DAMAGED WHEN THE DEVICE WAS INSERTED THROUGH THE NEEDLE GUIDE. AS THE ISSUE OCCURRED OUTSIDE THE PATIENT DURING PREPARATION, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: INSULATION PEELED. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN SUPERSLIM ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHEN THE ELECTRODE WAS INSERTED INTO THE INTRODUCER, IT WAS NOTED THAT THE INSULATION HAD PEELED APPROXIMATELY 10CM FROM THE DISTAL END OF THE INTRODUCER. IT WAS ALSO REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING INSERTION. THIS OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD" FOLLOWING THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN SUPERSLIM ELECTRODE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHEN THE ELECTRODE WAS INSERTED INTO THE INTRODUCER, IT WAS NOTED THAT THE INSULATION HAD PEELED APPROXIMATELY 10CM FROM THE DISTAL END OF THE INTRODUCER. IT WAS ALSO REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING INSERTION. THIS OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD" FOLLOWING THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133505 LEVEEN¿ SUPERSLIM¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262270 15042676

    Patients

    Seq Age Sex Outcome Treatment
    1