BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

    MDR report key: 2216147 · Received August 18, 2011

    Report

    Report Number
    9612355-2011-00027
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. CONCOMITANT PRODUCT USED DURING THE PROCEDURE: EZ STEER THERMOCOOL SF NAV CATHETER (PRODUCT NOT MARKETED IN THE US): MODEL #: D-1317-05-S, LOT #.: 15386368L. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS CONTACTED BY BIOSENSE WEBSTER FIELD SERVICE ENGINEER. THE CUSTOMER REFUSED TO SEND THIS GENERATOR FOR REPAIR SINCE THE ERROR HAS NOT BEEN DUPLICATED FOLLOWING THE REPORTING OF THIS COMPLAINT. THEY BELIEVED THAT THE ISSUE WAS DUE TO THE TROUBLESHOOTING THEY WERE PERFORMED. UPON CHANGING THE CATHETER AND THEY NOTICED A CHAR ON THE CATHETER TIP. THE CASE WAS COMPLETED WITHOUT ANY INCIDENT. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR SERIAL NUMBER (B)(4) SHOWED THAT NO MANUFACTURING OR TEST FAILURE WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE INITIAL COMPLAINT REPORTED WAS REGARDING HARDWARE ERROR ON THE STOCKERT GENERATOR SEEN AFTER ABLATION. THE EVENT DESCRIPTION PROVIDED BY THE CUSTOMER WAS NOT INDICATIVE OF A REPORTABLE COMPLAINT. UPON FURTHER FOLLOW-UP, ADDITIONAL INFORMATION STATED THE PRESENCE OF CHAR DURING THIS PROCEDURE. BIOSENSE WEBSTER BECAME AWARE OF THE CHAR DESCRIPTION MAKING IT REPORTABLE MALFUNCTION ON (B)(4) 2011. THE CHAR WAS STATED TO BE STUCK ON CATHETER TIP IN BETWEEN THE SPACE OF ELECTRODES #1 AND #2 COVERED WITH A THIN LAYER OF COAGULATED BLOOD. THE TOTAL DURATION OF PROCEDURE WAS APPROXIMATELY 5 HOURS. THE ABLATION TIME TO THE POINT THE CHAR OCCURRED WAS ABOUT 3 HOURS EVENT OCCURRED AFTER CHANGING FROM THE RIGHT SIDE OF THE LA TO THE LEFT SIDE. STOCKERT GENERATOR INDICATED HARDWARE ERROR 9 DURING SEVERAL TIMES. AFTER PLUGGING THE CATHETER OUT IT HAD CHARRING. THE PHYSICIAN CHANGED TO A NAVISTAR CATHETER TO FINISH THE CASE. THE GENERATOR WORKED PERFECTLY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1