BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 6041678 · Received October 19, 2016

    Report

    Report Number
    3008203003-2016-00034
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 26, 2016
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON THIS EVENT ON (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT WAS A (B)(6) YEAR MALE. PATIENT'S WEIGHT WAS 90 KG. THE PATIENT¿S DIAGNOSIS PRE-PROCEDURE WAS VENTRICULAR TACHYCHARDIA. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE PATIENT¿S REPORTED DISCOMFORT WAS THE PATIENT¿S CONDITION. THIS ISSUE DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PATIENT FULLY RECOVERED. MANUFACTURER'S REF. NO: (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM. A MAP SHIFT OF APPROXIMATELY 5CM OCCURRED DURING MAPPING AND NO ERROR MESSAGE POPULATED. THE MAP SHIFT WAS DISCOVERED BECAUSE OF THE INCONSISTENCY BETWEEN THE FAST ANATOMICAL MAP AND CONTACT FORCE. THERE WAS NO PATIENT MOVEMENT AND NO CARDIOVERSION WAS PERFORMED. THE PHYSICIAN REMAPPED THE CHAMBER TO CONTINUE THE PROCEDURE. THERE WAS AN HOUR AND HALF DELAY. ACCORDING TO THE PHYSICIAN THE DELAY ISSUE COULD NOT CAUSE OR CONTRIBUTE TO ANY SERIOUS INJURY OF THE PATIENT. ONLY DISCOMFORT WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE FULL SYSTEM TESTING WAS PERFORMED FOR CONFIDENCE AND PREVENTIVE MAINTENANCE. ALL CARTO 3 ACCEPTANCES TESTING PROCEDURE PASSED. THE BIOSENSE WEBSTER FIELD SERVICE REPRESENTATIVE CONFIRMED THAT THE CARTO 3 WAS OPERATIONAL. IT WAS DISCOVERED THAT THE MAP SHIFT ISSUE WAS NOT CAUSED BY THE CARTO SYSTEM. PHYSICIANS ARE INSTRUCTED ON THE OCCURRENCES THAT CAN LEAD TO MAP SHIFT AND THAT ARE NOT NOTIFIED BY THE SYSTEM. THE BIOSENSE WEBSTER FIELD SERVICE REPRESENTATIVE CONFIRMED THAT THE ISSUE WAS NOT DUPLICATED IN THE FOLLOWING SYSTEM USAGES. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO 3 SYSTEM. A MAP SHIFT OF APPROXIMATELY 5CM OCCURRED DURING MAPPING AND NO ERROR MESSAGE POPULATED. THE MAP SHIFT WAS DISCOVERED BECAUSE OF THE INCONSISTENCY BETWEEN THE FAST ANATOMICAL MAP AND CONTACT FORCE. THERE WAS NO PATIENT MOVEMENT AND NO CARDIOVERSION WAS PERFORMED. THE PHYSICIAN HAD TO REMAP THE CHAMBER TO CONTINUE THE PROCEDURE. THERE WAS AN HOUR AND HALF DELAY. ACCORDING TO THE PHYSICIAN THE DELAY ISSUE COULD NOT CAUSE OR CONTRIBUTE TO ANY SERIOUS INJURY OF THE PATIENT. ONLY DISCOMFORT WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE PROCEDURE DELAY WAS ASSESSED AS NOT REPORTABLE AS THERE WAS NO RISK TO THE PATIENT'S HEALTH STATUS INDICATED. THE PATIENT'S DISCOMFORT HAS BEEN ASSESSED AS NON SERIOUS AND THEREFORE NOT REPORTABLE AS THERE IS NO EVIDENCE OF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE MAP SHIFT WITH NO ERROR MESSAGE HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION AS SUCH MAP SHIFTS COULD POTENTIALLY BE CAUSED BY A SYSTEM MALFUNCTION AND THERE IS A POTENTIAL RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690894 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR