BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3071849 · Received April 22, 2013

    Report

    Report Number
    3008203003-2013-00050
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT AT THE END OF A PAROXYSMAL A-FIB PROCEDURE, A MAP SHIFT OCCURRED ON THE RIGHT INFERIOR VEIN. THE PHYSICIAN COULD SEE THE LASSO OUT OF THE MAP WHEREAS ON THE FLUOROSCOPY THE LASSO WAS ON THE RIGHT INFERIOR PULMONARY VEIN (RIPV). AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION ABOUT THE EVENT IT WAS CONFIRMED THAT THE MAP SHIFT WAS SEEN BECAUSE THE LASSO WAS OUTSIDE THE FAM WHILE THE PHYSICIAN WAS CHECKING FOR SIGNALS AFTER ABLATION. NO WARNING MESSAGE FROM CARTO 3 SYSTEM WAS GIVEN. THE AMOUNT OF THE MAP SHIFT WAS 10 MM. NO TROUBLESHOOTING WAS PERFORMED SINCE THE RIVP WAS ISOLATED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. NO RECORDS OR LOG FILES FOR THIS SYSTEM COULD BE OBTAINED. THE INFORMATION FOR THIS COMPLAINT WAS VERY LIMITED TO UNDERSTAND THE ROOT CAUSE OF THE ISSUE; THEREFORE, NO FURTHER INVESTIGATION COULD BE PERFORMED. IN ADDITION, THE MAP SHIFT ISSUE INITIALLY REPORTED WAS NOT DUPLICATED IN THE LAST CASES. THE DHR ASSOCIATED WITH CARTO 3 #12019 WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE REPAIR RECORD INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF A PAROXYSMAL A-FIB PROCEDURE, A MAP SHIFT OCCURRED ON THE RIGHT INFERIOR VEIN. THE PHYSICIAN COULD SEE THE LASSO OUT OF THE MAP WHEREAS ON THE FLUOROSCOPY THE LASSO WAS ON THE RIGHT INFERIOR PULMONARY VEIN (RIPV). THE CLINICAL SPECIALIST ASKED THE PHYSICIAN ABOUT SCREEN SHOT OF THE PATCH PLACEMENT BUT THE PHYSICIAN ANSWERED THAT THE FLUOROSCOPY WAS FUNCTIONING AT THE RECOMMENDED SID VALUES AND NOTHING WAS CLOSED TO THE LASSO CATHETER. THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES SINCE THE ISSUE OCCURRED AT THE END OF THE PROCEDURE AND THE ABLATION WAS ALREADY PERFORMED. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION ABOUT THE EVENT IT WAS CONFIRMED THAT THE MAP SHIFT WAS SEEN BECAUSE THE LASSO WAS OUTSIDE THE FAM WHILE THE PHYSICIAN WAS CHECKING FOR SIGNALS AFTER ABLATION. NO WARNING MESSAGE FROM CARTO 3 SYSTEM WAS GIVEN. THE AMOUNT OF THE MAP SHIFT WAS 10 MM. NO TROUBLESHOOTING WAS PERFORMED SINCE THE RIVP WAS ISOLATED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172726 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1