BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLANAV CATHETERS

    MDR report key: 18194318 · Received November 22, 2023

    Report

    Report Number
    2124215-2023-66033
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    June 7, 2022
    Report Date
    November 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    PER LITERATURE REVIEW, IT WAS REPORTED THAT: AT GUNMA PREFECTURAL CARDIOVASCULAR CENTER FROM SEPTEMBER 2019 TO NOVEMBER 2020, 157 PATIENTS WERE ENROLLED TO THIS STUDY WHO WERE SCHEDULED TO UNDERGO AN INITIAL EXTENSIVE PVI OF AF GUIDED BY THE RHYTHMIA SYSTEM, USING THE INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER. ALL PATIENTS UNDERWENT TRANSESOPHAGEAL AND OR INTRACARDIAC ECHOCARDIOGRAPHY TO RULE OUT ANY INTRACARDIAC THROMBI BEFORE THE ABLATION PROCEDURE AND CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) OR PLAIN MAGNETIC RESONANCE (MR) IMAGING FOR ASSESSMENT OF THE PULMONARY VEIN AND LEFT ATRIUM ANATOMY. DURING THE ABLATION PROCEDURE, THE ACTIVATED CLOTTING TIME WAS MAINTAINED BETWEEN 300 AND 400 S BY A CONTINUOUS AND ADDITIONAL BOLUS HEPARIN INFUSION. ALL PATIENTS RECEIVED DEEP CONSCIOUS SEDATION THROUGHOUT THE PROCEDURE USING PROPOFOL OR DEXMEDETOMIDINE, AND PENTAZOCINE. THE CATHETER WAS INTRODUCED INTO THE LEFT ATRIUM THROUGH THREE TRANSSEPTAL SHEATHS (NON-BOSTON SCIENTIFIC BRAND). THE PVO STARTED IN AN ORDER FROM RIGHT PULMONARY VEINS (RPV) TO LEFT PULMONARY VEINS (LPV) IN 76 PATIENTS AND FROM THE LPVS TO RPVS IN 81 PATIENTS AND WAS SUCCESSFULLY COMPLETED IN ALL PATIENTS. A TOTAL OF 28 PATIENTS UNDERWENT ADDITIONAL ABLATION PROCEDURES OTHER THAN THE PVI AND CAVO TRICUSPID ISTHMUS LINEAR ABLATION. PROCEDURE-RELATED COMPLICATIONS OCCURRED IN FOUR PATIENTS: A CARDIAC TAMPONADE IN ONE, WHICH COULD BE MANAGED WITH PERCUTANEOUS PERICARDIAL DRAINAGE, GASTRIC HYPOMOTILITY IN TWO, WHICH SPONTANEOUSLY RESOLVED, AND A FEMORAL HEMATOMA IN ONE, WHICH COULD BE MANAGED WITH A LOCAL PRESSURE APPLICATION. ALL ENDOCARDIAL RESIDUAL AND RECONNECTED GAPS WERE SUCCESSFULLY ELIMINATED WITH RF APPLICATIONS AT THE GAP SITES ON THE INITIAL PVI LINES. NAKAMURA K, SASAKI T, MINAMI K, ET AL., PREVALENCE, CHARACTERISTICS, AND PREDICTORS OF ENDOCARDIAL AND NON-ENDOCARDIAL CONDUCTION GAPS DURING LOCAL IMPEDANCE-GUIDED EXTENSIVE PULMONARY VEIN ISOLATION OF ATRIAL FIBRILLATION WITH HIGH-RESOLUTION MAPPING. J CARDIOVASC ELECTROPHYSIOL. 2021;32: 2045-2059. HTTPS://DOI.ORG/10.1111/JCE.15152.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944195 INTELLANAV CATHETERS catheter, percutaneous, cardiac ablation, for treatment of atrial flutter OAD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention