BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 18267837 · Received December 5, 2023

    Report

    Report Number
    3005334138-2023-00546
    Event Type
    Injury
    Date Received
    December 5, 2023
    Report Date
    December 27, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN HEARTRHYTHM CASE REPORTS (B)(4). ELSEVIER INC. ( (B)(6) 2023) "A SERIOUS COMPLICATION OF HIGH-POWER SHORT-DURATION RADIOFREQUENCY ATRIAL FIBRILLATION ABLATION ASSOCIATED WITH GENETIC HYPODYSFIBRINOGENEMIA"; KALABA, FRANK MD DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS, BLOOD TRANSFUSIONS, AND STERNOTOMY TO STABILIZE THE PATIENT. DURING A HIGH POWER SHORT DURATION RADIOFREQUENCY ABLATION (50 W FOR 10 SECONDS) OF THE LEFT ATRIAL APPENDAGE RIDGE NEAR THE JUNCTION OF THE ANTERIOR ASPECT OF THE LEFT SUPERIOR AND INFERIOR PULMONARY VEINS, AN IMPEDANCE RISE WAS NOTED AND A STEAM POP OCCURRED. HYPOTENSION WAS OBSERVED AND INTRACARDIAC ECHOCARDIOGRAPHY CONFIRMED A LARGE PERICARDIAL EFFUSION. PROTAMINE WAS ADMINISTERED AND A PERICARDIOCENTESIS WAS PERFORMED BUT THE EFFUSION WAS NOT RESOLVED. (B)(4) UNITS OF PACKED RED BLOOD CELLS, (B)(4) UNITS OF FRESH FROZEN PLASMA, AND 4 PACKS OF PLATELETS WERE ADMINISTERED. THE EFFUSION PERSISTED SO THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR EMERGENT STERNOTOMY. A PERFORATION WAS LOCATED AT THE BASE OF THE LEFT ATRIAL APPENDAGE AND WAS REPAIRED. THE PATIENT RECOVERED AND WAS DISCHARGED HOME 3 DAYS LATER. THE PATIENT WAS PLACED ON LOW-DOSE HEPARIN AFTER THE SURGERY AND LATER TRANSITIONED TO ORAL ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049240 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 Required Intervention| L