BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 20902280 · Received December 11, 2024

    Report

    Report Number
    3008452825-2024-00707
    Event Type
    Injury
    Date Received
    December 11, 2024
    Report Date
    February 21, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN HEARTH RHYTHM CASE REPORTS, HEART RHYTHM SOCIETY, 9.11: 800-801. ELSEVIER INC. (NOV 2023) "A SERIOUS COMPLICATION OF HIGH-POWER SHORT-DURATION RADIOFREQUENCY ATRIAL FIBRILLATION ABLATION ASSOCIATED WITH GENETIC HYPODYSFIBRINOGENEMIA"; FRANK KALABA DURING A HIGH-POWER SHORT DURATION RADIOFREQUENCY ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED REQUIRING SURGERY TO STABILIZE THE PATIENT. WHILE PERFORMING ABLATION (50 W FOR 10 SECONDS) OF THE LEFT ATRIAL APPENDAGE (LAA) RIDGE NEAR THE JUNCTION OF THE ANTERIOR ASPECT OF THE LEFT SUPERIOR AND INFERIOR PULMONARY VEINS, THE PATIENT HAD AN IMPEDANCE RISE AND A STEAM POP. HYPOTENSION WAS NOTED AND INTRACARDIAC ECHOCARDIOGRAPHY CONFIRMED A LARGE PERICARDIAL EFFUSION. DESPITE HEPARIN REVERSAL WITH PROTAMINE AND EMERGENT PERICARDIOCENTESIS, THERE WAS CONTINUED RAPID REACCUMULATION OF PERICARDIAL BLOOD. BLOOD PRODUCT REPLACEMENT WITH 6 UNITS OF PACKED RED BLOOD CELLS, 4 UNITS OF FRESH FROZEN PLASMA, AND 4 PACKS OF PLATELETS WAS ADMINISTERED. WITH NO CESSATION OF BLEEDING, THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR EMERGENT STERNOTOMY. PERSISTENT BLEEDING FROM A 5-MMSIZE PERFORATION AT THE BASE OF THE LAA WAS FOUND AND REPAIR OF THIS AREA WITH LAA LIGATION WAS PERFORMED. HE WAS PLACED ON LOW-DOSE HEPARIN AFTER THE SURGERY AND LATER TRANSITIONED TO ORAL ANTICOAGULATION. THE PATIENT RECOVERED WELL FROM SURGERY AND WAS DISCHARGED 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2443376 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Life Threatening| R