BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F

    MDR report key: 13954833 · Received March 30, 2022

    Report

    Report Number
    3008452825-2022-00189
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    January 19, 2022
    Report Date
    April 21, 2022
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    OAE
    UDI-DI
    05415067027641
    PMA / PMN Number
    P130026
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FSCA NUMBER: 3005334138-3/22/22-001-R PRODUCT #1 PI MAIN [PI-2022-0010499-01] THE REPORTED EVENT OF A CONTACT FORCE ISSUE COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS; HOWEVER, THIS BATCH IS ASSOCIATED WITH A POTENTIAL RECOGNITION ISSUE AND LOSS OF FUNCTIONALITY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. AS A RESULT OF THIS ISSUE, ABBOTT IS PERFORMING FURTHER INVESTIGATION. PRODUCT #2 PI MAIN [PI-2022-0010499-02] THE REPORTED EVENT OF A CONTACT FORCE ISSUE COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS; HOWEVER, THIS BATCH IS ASSOCIATED WITH A POTENTIAL RECOGNITION ISSUE AND LOSS OF FUNCTIONALITY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. AS A RESULT OF THIS ISSUE, ABBOTT IS PERFORMING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, G3, G6, H2, H3, H6, H10. THE RETURNED DEVICE WAS INADVERTENTLY PROGRAMMED DURING MANUFACTURING, CONSISTENT WITH A LOSS IN CONTACT FORCE FUNCTIONALITY AND WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    DURING AN ATYPICAL RIGHT ATRIAL FLUTTER PROCEDURE TWO TACTICATH SE ABLATION CATHETERS EXPERIENCED THE SAME PROBLEM: JUST AFTER CONNECTING THE CATHETER TO THE SYSTEM IT WAS PROPERLY RECOGNIZED BY THE SYSTEM BUT THE CONTACT FORCE VALUE WASN'T DISPLAYED (IT REMAINED 0 G, PURPLE). CHECKED ALL THE CONNECTIONS AND REBOOTED THE TACTISYS WITHOUT BEING ABLE TO FIX THE ISSUE. ALSO CHECKED THE TWO CATHETERS WITH A SECOND TACTISYS BUT THE PROBLEM PERSISTED. IT WAS DECIDED TO OPEN A THIRD TACTICATH SE WITH DIFFERENT LOT NUMBER: IT WAS PROPERLY RECOGNIZED AND THE CONTACT FORCE WAS FINE TOO. WE SUCCESSFULLY PERFORMED THE PROCEDURE WITH NO ADVERSE EVENTS FOR THE PATIENT.

    Description of Event or Problem · 0

    DURING ATYPICAL ATRIAL FLUTTER PROCEDURE, CATHETER WAS RECOGNIZED BY SYSTEM BUT CONTACT FORCE VALUE DID NOT DISPLAY. CATHETER WAS REPLACED AND ISSUE STILL PERSISTED. TACTISYS WAS REBOOTED AND ALL CONNECTIONS WERE CHECKED BUT THE PROBLEM CONTINUED. BOTH CATHETERS WERE CONNECTED TO ANOTHER TACTISYS BUT HAD THE SAME ISSUE. A THIRD CATHETER FROM A DIFFERENT LOT NUMBER WAS USED WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE EFFECTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043670 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ BID CURVE D-F CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL, COSTA RICA LTDA A-TCSE-DF 8190438 05415067027641

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female