BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER

    MDR report key: 18997881 · Received March 28, 2024

    Report

    Report Number
    3008452825-2024-00172
    Event Type
    Injury
    Date Received
    March 28, 2024
    Report Date
    April 5, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3. 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 ADVERSE EVENTS REMAIN UNKNOWN. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 3008452825-2024-00173. THE FOLLOWING WAS PUBLISHED IN THE JACC: CLINICAL ELECTROPHYSIOLOGY 10.2: 193-202. ELSEVIER INC. (FEB 2024) IN AN ARTICLE TITLED "STROKE AND BLEEDING RISKS OF ENDOCARDIAL ABLATION FOR VENTRICULAR ARRHYTHMIAS"; HASEGAWA, KANAE; VOL. 10, NO. 2, 2024; HASEGAWA ET AL. A PROSPECTIVE ASSESSMENT FOR COMPLICATIONS WAS PERFORMED FOR 663 ENDOCARDIAL RADIOFREQUENCY CATHETER ABLATION PROCEDURES IN 616 CONSECUTIVE PATIENTS (MEDIAN AGE 64 YEARS [Q1-Q3: 54-73 YEARS], 70.3% MEN, 71.6% WITH CARDIOMYOPATHY, 44.5% WITH SUSTAINED VENTRICULAR TACHYCARDIA). ELEVEN PERICARDIAL EFFUSIONS OCCURRED: THREE REQUIRED SURGICAL REPAIR AND FIVE REQUIRED PERCUTANEOUS PERICARDIAL DRAINAGE. FIVE EMBOLIC EVENTS OCCURRED: ONE TRANSIENT ISCHEMIC ATTACK, TWO STROKES AND TWO PULMONARY EMBOLI. ADDITIONALLY, ELEVEN HEART BLOCKS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928461 FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O