BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 4204396 · Received October 27, 2014

    Report

    Report Number
    3008203003-2014-00070
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY: (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE CUSTOMER EXPERIENCED A MAP SHIFT APPROXIMATELY 4 CM WITHOUT ANY ERROR ON THE CARTO SYSTEM. THE MAP SHIFT WAS NOTICED BY FLUORO WHEN PHYSICIAN WAS ON POSTERIOR WALL BY FLUORO, ICE AND CARTO MAP HAD ABLATOR ON SEPTUM. THE CASE WAS COMPLETED WITH THE MAP SHIFT WITHOUT ANY PATIENT CONSEQUENCE. THE PIU WAS REPLACED AND THE SYSTEM PASSED ALL TESTS. THE PIU WAS SENT TO MANUFACTURER (HTC) FOR RETURN MERCHANDIZE AUTHORIZATION INVESTIGATION PROCESS. THE CUSTOMER COMPLAINT REGARDING MAP SHIFT ISSUE WAS NOT CONFIRMED SINCE THE MAP SHIFT WAS NOT DUPLICATED. DURING INVESTIGATION, IT WAS FOUND, THE PIU FOUND FAILED AS WELL AS ACL CARD. HOWEVER THE PIU PASSED AQUARIUM TESTS WITH A FEW TYPES OF CATHETERS, SERVICE JIG UTILITY TESTS (SJU) WAS DONE. THE PIU CHECKED AND BUILD CURRENT TO POSITION MAPPING (CPM) WITH LASSO AND MAP. THE PIU PASSED ISOLATION TEST. THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH CARTO 3 SYSTEM # (B)(4) WAS REVIEWED AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. IN ADDITION, A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS AND RESOLVE THIS DISCONNECTION IN THE ACL TX CARD ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE CUSTOMER EXPERIENCED A MAP SHIFT APPROXIMATELY 4 CM WITHOUT ANY ERROR ON THE CARTO SYSTEM. THE MAP SHIFT WAS NOTICED BY FLUORO WHEN PHYSICIAN WAS ON POSTERIOR WALL BY FLUORO, ICE AND CARTO MAP HAD ABLATOR ON SEPTUM. THE CASE WAS COMPLETED WITH THE MAP SHIFT WITHOUT ANY PATIENT CONSEQUENCE. PER CARTO 3 IFU MAP SHIFT WITHOUT INDICATION MAY OCCUR IF BACK PATCHES MOVE ALONG Z- AXIS. BEFORE APPLYING RF ENERGY, VISUALLY VERIFY CORRECTNESS OF THE TIP POSITION OF THE MAPPING CATHETER IN RELATION TO THE VISUALIZED MAP. USE YOUR COMMON CLINICAL PRACTICE, SUCH AS FLUOROSCOPY OR INSPECTION OF IC SIGNALS, TO VERIFY THE LOCATION OF THE CATHETERS THROUGHOUT THE PROCEDURE. FAILURE TO DO SO MIGHT RESULT IN INCORRECT PLACEMENT OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684806 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1