BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 8516422 · Received April 15, 2019

    Report

    Report Number
    2029046-2019-02988
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 19, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM. THE PENTARAY CATHETER WAS USED TO FAST ANATOMICAL MAP (FAM) THE LEFT ATRIUM (LA). AFTER THE PENTARAY CATHETER WAS EXCHANGED FOR THE ABLATION CATHETER, THERE WAS A MAP SHIFT ON A CARTO® 3 SYSTEM. THE ABLATION CATHETER APPEARED 1 CM OUTSIDE THE FAM MAP. THERE WERE NO ERRORS ON THE SYSTEM AND NO PATIENT MOVEMENT. THE BIOSENSE WEBSTER INC. REPRESENTATIVE RESET VISUALIZATION WITHOUT RESOLUTION. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE INSPECTED THE AREA AROUND THE PATIENT FOR METAL INTERFERENCE AND FOUND A CLAMP WHICH WAS USED TO SECURE THE BEAR HUGGER WARMER TO THE TABLE. THIS WAS CLOSE TO THE LOCATION PAD. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE REMOVED THE CLAMP AND A NEW FAM MAP OF THE LA WAS CREATED WITH THE PENTARAY CATHETER. THE PROCEDURE WAS CONTINUED SUCCESSFULLY. IT WAS ALSO NOTED THAT A TEE PROBE SITS IN THE PATIENT'S ESOPHAGUS DURING THE PROCEDURE TO MOVE THE ESOPHAGUS WHEN NEEDED. THIS IS A ROUTINE PRACTICE FOR THE PHYSICIAN AND DOES NOT USUALLY CAUSE PROBLEMS, BUT MAY CONTRIBUTE TO METAL INTERFERENCE. METAL VALUES DID NOT CHANGE DURING THE CASE. A RESPONSE WAS RECEIVED ON APRIL 9, 2019, STATING THAT NO CARDIOVERSION WAS PERFORMED AT ANY POINT DURING THE PROCEDURE. THE BIOSENSE WEBSTER INC. FIELD SERVICE ENGINEER SPOKE WITH THE BIOSENSE WEBSTER, INC. FIELD REPRESENTATIVE. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE CONFIRMED THAT AFTER INSPECTION THE AREA AROUND THE PATIENT, FOUND THAT THE CLAMP USED TO SECURE THE BAIR HUGGER WARMER TO THE TABLE WAS CLOSE TO THE LOCATION PAD AND CAUSED THE MAP SHIFT ISSUE. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE REMOVED THE BAIR HUGGER CLAMP, A NEW FAST ANATOMICAL MAP OF THE LEFT ATRIUM WAS CREATED WITH THE PENTARAY CATHETER WITHOUT FURTHER ISSUES. THE PROCEDURE WAS CONTINUED SUCCESSFULLY. THE SYSTEM IS READY FOR USE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES, WHICH ARE RELATED TO THE REPORTED ISSUE WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT. MANUFACTURER'S REFERENCE NUMBER:(B)(4).

    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. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM AND A MAP SHIFT OCCURRED WITH NO ERROR MESSAGE AND NO PATIENT MOVEMENT OR CARDIOVERSION. THE PENTARAY CATHETER WAS USED TO FAST ANATOMICAL MAP (FAM) THE LEFT ATRIUM (LA). AFTER THE PENTARAY CATHETER WAS EXCHANGED FOR THE ABLATION CATHETER ,THERE WAS A MAP SHIFT ON A CARTO® 3 SYSTEM. THE ABLATION CATHETER APPEARED 1 CM OUTSIDE THE FAM MAP. THERE WERE NO ERRORS ON THE SYSTEM AND NO PATIENT MOVEMENT. THE BIOSENSE WEBSTER INC. REPRESENTATIVE RESET VISUALIZATION WITHOUT RESOLUTION. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE INSPECTED THE AREA AROUND THE PATIENT FOR METAL INTERFERENCE AND FOUND A CLAMP WHICH WAS USED TO SECURE THE BEAR HUGGER WARMER TO THE TABLE. THIS WAS CLOSE TO THE LOCATION PAD. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE REMOVED THE CLAMP AND A NEW FAM MAP OF THE LA WAS CREATED WITH THE PENTARAY CATHETER. THE PROCEDURE WAS CONTINUED SUCCESSFULLY. IT WAS ALSO NOTED THAT A TEE PROBE SITS IN THE PATIENT'S ESOPHAGUS DURING THE PROCEDURE TO MOVE THE ESOPHAGUS WHEN NEEDED. THIS IS A ROUTINE PRACTICE FOR THE PHYSICIAN AND DOES NOT USUALLY CAUSE PROBLEMS, BUT MAY CONTRIBUTE TO METAL INTERFERENCE. METAL VALUES DID NOT CHANGE DURING THE CASE. A RESPONSE WAS RECEIVED ON APRIL 9, 2019, STATING THAT NO CARDIOVERSION WAS PERFORMED AT ANY POINT DURING THE PROCEDURE. THE MAP SHIFT WITH NO ERROR MESSAGE AND NO PATIENT MOVEMENT OR CARDIOVERSION, WAS ASSESSED AS A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308561 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1