BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEEN¿ SUPERSLIM¿

    MDR report key: 2906995 · Received January 10, 2013

    Report

    Report Number
    3005099803-2013-00033
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 25, 2012
    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

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THAT FOUND THE ARRAY TO BE RETRACTED AND THE CANNULA TO BE BENT NEAR THE DISTAL TIP. THROUGH FUNCTIONAL TESTING, SLIGHT RESISTANCE WAS NOTED DUE TO THE BENT CANNULA WHEN ATTEMPTING TO EXTEND AND RETRACT. THE ARRAY TINES WERE FOUND TO BE EVENLY SPACED AND UN-DEFORMED. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) THE REPORTED EVENT: ELECTRODE NEEDLE BENT. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE IN THE LIVER ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONCE THE DEVICE WAS INSERTED INTO THE LIVER THE NEEDLES WERE ATTEMPTED TO BE DEPLOYED; HOWEVER RESISTANCE WAS MET. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE NEEDLES WERE BENT. THE DEVICE WAS PUT TO THE SIDE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012, THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE IN THE LIVER ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONCE THE DEVICE WAS INSERTED INTO THE LIVER THE NEEDLES WERE ATTEMPTED TO BE DEPLOYED; HOWEVER RESISTANCE WAS MET. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE NEEDLES WERE BENT. THE DEVICE WAS PUT TO THE SIDE AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15412 LEVEEN¿ SUPERSLIM¿ ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - SPENCER M001262290 14913085

    Patients

    Seq Age Sex Outcome Treatment
    1