BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 13451246 · Received February 4, 2022

    Report

    Report Number
    3005334138-2022-00066
    Event Type
    Injury
    Date Received
    February 4, 2022
    Report Date
    February 8, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE: AGILIS INTRODUCER.

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE: AGILIS INTRODUCER.

    Additional Manufacturer Narrative · 0

    EVENTS OF PERICARDIAL EFFUSION, LEFT BUNDLE BRANCH BLOCK, AND PULMONARY EDEMA WERE REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENTS REMAIN UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: (B)(4). THE FOLLOWING WAS PUBLISHED IN JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY TITLED, "IMPACT OF A HIGH-DENSITY GRID CATHETER ON LONG-TERM OUTCOMES FOR STRUCTURAL HEART DISEASE VENTRICULAR TACHYCARDIA ABLATION", PUBLISHED: (B)(6) 2021, RICCARDO PROIETTI MD; ET AL. SUBSTRATE MAPPING HAS HIGHLIGHTED THE IMPORTANCE OF TARGETING DIASTOLIC CONDUCTION CHANNELS AND LATE POTENTIALS DURING VENTRICULAR TACHYCARDIA (VT) ABLATION. STATE-OF-THE-ART MULTIPOLAR MAPPING CATHETERS HAVE ENHANCED MAPPING CAPABILITIES. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE WHETHER LONG-TERM OUTCOMES WERE IMPROVED WITH THE USE OF A HD GRID MAPPING CATHETER COMBINING COMPLEMENTARY MAPPING STRATEGIES IN PATIENTS WITH STRUCTURAL HEART DISEASE VT. TWO PATIENTS SUFFERED PERICARDIAL EFFUSIONS, ONE OF WHICH REQUIRED A PERICARDIAL DRAIN. ONE PATIENT DEVELOPED LEFT BUNDLE BRANCH BLOCK NECESSITATING DEVICE UPGRADE TO BIVENTRICULAR PACING AND ONE PATIENT SUFFERED PULMONARY EDEMA. TWO PATIENTS THAT SUFFERED FEMORAL VASCULAR COMPLICATIONS, ONE WITH A GROIN HEMATOMA, AND ONE PATIENT WITH A PSEUDOANEURYSM.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 3008452825-2022-00042. THE FOLLOWING WAS PUBLISHED IN JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY TITLED, "IMPACT OF A HIGH-DENSITY GRID CATHETER ON LONG-TERM OUTCOMES FOR STRUCTURAL HEART DISEASE VENTRICULAR TACHYCARDIA ABLATION", PUBLISHED: 04 JANUARY 2021, RICCARDO PROIETTI MD; ET AL. SUBSTRATE MAPPING HAS HIGHLIGHTED THE IMPORTANCE OF TARGETING DIASTOLIC CONDUCTION CHANNELS AND LATE POTENTIALS DURING VENTRICULAR TACHYCARDIA (VT) ABLATION. STATE-OF-THE-ART MULTIPOLAR MAPPING CATHETERS HAVE ENHANCED MAPPING CAPABILITIES. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE WHETHER LONG-TERM OUTCOMES WERE IMPROVED WITH THE USE OF A HD GRID MAPPING CATHETER COMBINING COMPLEMENTARY MAPPING STRATEGIES IN PATIENTS WITH STRUCTURAL HEART DISEASE VT. TWO PATIENTS SUFFERED PERICARDIAL EFFUSIONS, ONE OF WHICH REQUIRED A PERICARDIAL DRAIN. ONE PATIENT DEVELOPED LEFT BUNDLE BRANCH BLOCK NECESSITATING DEVICE UPGRADE TO BIVENTRICULAR PACING AND ONE PATIENT SUFFERED PULMONARY EDEMA. TWO PATIENTS THAT SUFFERED FEMORAL VASCULAR COMPLICATIONS, ONE WITH A GROIN HEMATOMA, AND ONE PATIENT WITH A PSEUDOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234792 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 Unknown Required Intervention