BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 2840968 · Received November 20, 2012

    Report

    Report Number
    3008203003-2012-00063
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 17, 2012
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE #:(B)(4). IT WAS REPORTED THAT THE CARTO 3 SYSTEM HAD NOISE IN IC SIGNALS WHEN RF WAS APPLIED AND ELECTRICAL STIMULATION WAS DONE SIMULTANEOUSLY. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT, ADDITIONAL INFORMATION STATED THAT THE SIGNAL NOISE OCCURRED IN ALL CHANNELS, INCLUDING BS ECG AND IC RECORDINGS ON BOTH CARTO AND EP RECORDING SYSTEMS AT THE SAME TIME MAKING THIS EVENT REPORTABLE. THE SYSTEM WAS REMOVED FROM THE ACCOUNT AND SENT TO CARTO MANUFACTURER (HTC) FOR FURTHER INVESTIGATION. HTC TESTED THE SYSTEM AND REPORTED THAT THE COMPLAINT WAS CONFIRMED. OPTO-SWITCHES OF ECG CARD WERE FOUND DEFECTIVE CAUSING NOISE ON CHANNELS 1-2 AND 5-6. THE OPTO-SWITCHES DEFECTIVES WERE REPLACED WITH NEW ONES AND THE ISSUE WAS SOLVED. THE DHR ASSOCIATED WITH CARTO 3 # 11474 WAS REVIEWED AND THERE WERE NOT ANY DISCREPANCIES NOTED. THE SYSTEM MET ALL SPECIFICATIONS UPON ITS RELEASE. AN INTERNAL CORRECTIVE ACTION WAS OPENED TO ADDRESS OPTO-SWITCHES AND TVS FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARTO 3 SYSTEM HAD NOISE IN IC SIGNALS WHEN RF WAS APPLIED AND ELECTRICAL STIMULATION WAS DONE SIMULTANEOUSLY. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT, ON (B)(6) 2012, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SIGNAL NOISE OCCURRED IN ALL CHANNELS, INCLUDING BS ECG AND IC RECORDINGS ON BOTH CARTO AND EP RECORDING SYSTEMS AT THE SAME TIME MAKING THIS EVENT REPORTABLE. THE PHYSICIAN STATED THAT IN THE FIRSTS 10S OF ABLATION AND PACING (BY A DIAGNOSTIC CATHETER) IT WAS IMPOSSIBLE TO SEE ANY SIGNAL, AFTER STABILIZATION OF THE NOISE, THERE WAS A 0,3MV NOISE IN MAP 1-2. THE PHYSICIAN WAS NOT ABLE TO INTERPRET THE SIGNALS DURING THE FIRSTS 10S, AFTER 10S, 15S HE DID IT WITH EXTREME DIFFICULTY. AFTER SOME TIME WITH THE SAME NOISE, HE CHOSE TO PACE AND ABLATE ALTERNATELY. WHEN THE PHYSICIAN WAS ABLATING OR PACING ALONE, THERE WAS NOT SIGNIFICANT NOISE. THE PROCEDURE WAS COMPLETED BUT IT TOOK MORE TIME TO FINISH IT. BASED ON THE INFORMATION PROVIDED, THE ALERT DATE WAS CHANGED TO (B)(4) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1