BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 8668054 · Received June 4, 2019

    Report

    Report Number
    2029046-2019-03207
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 15, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 6, 2019, ADDITIONAL INFORMATION, PHOTOS, WERE RECEIVED. THE IMAGES WERE REVIEWED, AND IT WAS REPORTED THAT THERE WAS A NOTICEABLE MAP SHIFT AS ALL THE CATHETERS APPEAR OUTSIDE THE GEOMETRY. INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A CARTO® 3 SYSTEM AND IT WAS DESCRIBED THAT THERE WAS A MAP SHIFT WITH NO ERROR MESSAGE OR NO PATIENT MOVEMENT/CARDIOVERSION. INITIALLY, IT WAS REPORTED THAT WHEN THEY INTRODUCED THE .035 GUIDE WIRE THAT COMES WITH THE SL1 SHEATH, THERE WAS A NOTICEABLE SHIFT IN CATHETER POSITION ON ALL CATHETERS. THERE WERE NO ERROR CODES THAT WERE DISPLAYED, AND THE METAL VALUES WERE WITHIN SPECIFICATIONS. THE CATHETERS WOULD RETURN TO THEIR NORMAL/CORRECT POSITIONS WHEN THE GUIDE WIRE WAS REMOVED. THE FIELD SERVICE ENGINEER PERFORMED FULL ATP ON THE SYSTEM AND FOUND NO ISSUES. THE FIELD SERVICE ENGINEER FOLLOWED UP WITH THE BIOSENSE WEBSTER, INC. REPRESENTATIVE WHO CALLED THE ISSUE IN, AND CONFIRMED THAT THERE HAS NOT BEEN ANY ISSUES SINCE. NO ADDITIONAL INVESTIGATION CAN BE PERFORMED AS THE DATA RELATED TO THE ISSUE WAS NEVER SENT TO THE BIOSENSE WEBSTER, INC. HAIFA TECHNOLOGY CENTER. THE SYSTEM WAS OPERATIONAL. 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 # (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ON JULY 9, 2019, THE PRODUCT INVESTIGATION WAS REOPENED AS IT WAS DETERMINED THAT THE IMAGES RECEIVED FROM THE BIOSENSE WEBSTER, INC. REPRESENTATIVE WERE INADVERTENTLY OMITTED FROM THE INVESTIGATION PROCESS. THE IMAGES HAVE NOW BEEN REVIEWED AND IT WAS DETERMINED THAT THE PICTURES THAT WERE PROVIDED DO NOT PROVIDE ANY USEFUL INFORMATION FOR INVESTIGATION. IN ORDER TO PROPERLY ANALYZE MAP SHIFT COMPLAINTS, FULL RECORDINGS FROM THE CASE ARE NEEDED. WITHOUT THE FULL RECORDINGS AN INVESTIGATION IS NOT POSSIBLE. THIS DATA WAS REQUESTED, AND IT WAS CONFIRMED THAT THE RECORDINGS ARE NOT AVAILABLE. NO ADDITIONAL INVESTIGATION CAN BE PERFORMED AS THE DATA RELATED TO THE ISSUE WAS NOT MADE AVAILABLE TO THE DEVICE MANUFACTURER. THE SYSTEM IS OPERATIONAL. MANUFACTURER'S REFERENCE # (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 REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A CARTO® 3 SYSTEM AND IT WAS DESCRIBED THAT THERE WAS A MAP SHIFT WITH NO ERROR MESSAGE OR NO PATIENT MOVEMENT/CARDIOVERSION. INITIALLY, IT WAS REPORTED THAT WHEN THEY INTRODUCED THE .035 GUIDE WIRE THAT COMES WITH THE SL1 SHEATH, THERE WAS A NOTICEABLE SHIFT IN CATHETER POSITION ON ALL CATHETERS. THERE WERE NO ERROR CODES THAT WERE DISPLAYED, AND THE METAL VALUES WERE WITHIN SPECIFICATIONS. THE CATHETERS WOULD RETURN TO THEIR NORMAL/CORRECT POSITIONS WHEN THE GUIDE WIRE WAS REMOVED. THE ISSUE WAS REPRODUCIBLE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ON MAY 17, 2019, ADDITIONAL INFORMATION WAS PROVIDED, AND IT WAS NOTED THAT THE ISSUE WAS SEEN DURING MAPPING, DURING THE ADVANCEMENT OF THE WIRE TO GO TRANSSEPTAL. THE APPROXIMATE DIFFERENCE IN CATHETER LOCATION BEFORE AND AFTER MAP SHIFT WAS APPROXIMATELY 10 MM. IT WAS ALSO NOTED THAT THERE WAS NO CARDIOVERSION PERFORMED, AS THE PATIENT WAS UNDER GENERAL ANESTHESIA, THEREFORE THERE WAS NO MOVEMENT. THE ISSUE OF MAP SHIFT WITH NO ERROR MESSAGE OR NO PATIENT MOVEMENT/CARDIOVERSION WAS ASSESSED AS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459232 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1