BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 17238995 · Received June 30, 2023

    Report

    Report Number
    3008452825-2023-00285
    Event Type
    Injury
    Date Received
    June 30, 2023
    Report Date
    July 17, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 HEART 109.12: 921-928. BMJ PUBLISHING GROUP. (JUN 1, 2023) "IMPACT OF PRE-EXISTING LEFT ATRIAL APPENDAGE OCCLUDER ON CATHETER ABLATION OF ATRIAL FIBRILLATION" JIEN-JIUN CHEN. FROM OUR ATRIAL FIBRILLATION REGISTRY, (B)(4) DRUG-REFRACTORY PATIENTS WITH LAAO (LEFT ATRIAL APPENDAGE OCCLUSION) WERE INCLUDED FOR PULMONARY VEIN ISOLATION. A BALANCED CONTROL GROUP WITH (B)(4) PATIENTS WITHOUT LAAO RECEIVING PULMONARY VEIN ISOLATION WERE INCLUDED FOR COMPARISON. THE RATE OF PROCEDURE-RELATED PERICARDIAL EFFUSION WAS SIMILAR BETWEEN THE TWO GROUPS WITH (B)(4) TOTAL. THERE WERE (B)(4) PERIPROCEDURAL STROKES. IN THE TWO PATIENTS WITH PERIPROCEDURAL STROKE, THE POSSIBILITY THAT THE CATHETER TOUCHED THE OCCLUDER DEVICE AND CAUSED MICROTHROMBUS EMBOLIZATION COULD NOT BE RULED OUT. THEREFORE, IT WAS PROPOSED NOT TO TOUCH THE DEVICE AS MUCH AS POSSIBLE BY USING A COMPUTED TOMOGRAPHY AND 3D MAPPING MERGE TO GUIDE THE EXACT LOCATION OF THE OCCLUDER WHEN ABLATING THE LEFT-SIDED PULMONARY VEIN, OR IN CARTO, THE CT COULD BE USED TO GUIDE THE ABLATION. THE PHYSICIAN DOES NOT ALLEGE THAT THE ADVISOR HD GRID CATHETER OR BRK TRANSSEPTAL NEEDLE CAUSED OR CONTRIBUTED TO THE PROCEDURE-RELATED PERICARDIAL EFFUSIONS OR PERIPROCEDURAL STROKES.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN HEART 109.12: 921-928. BMJ PUBLISHING GROUP. (JUN 1, 2023) "IMPACT OF PRE-EXISTING LEFT ATRIAL APPENDAGE OCCLUDER ON CATHETER ABLATION OF ATRIAL FIBRILLATION" JIEN-JIUN CHEN. FROM OUR ATRIAL FIBRILLATION REGISTRY, 65 DRUG-REFRACTORY PATIENTS WITH LAAO (LEFT ATRIAL APPENDAGE OCCLUSION) WERE INCLUDED FOR PULMONARY VEIN ISOLATION. A BALANCED CONTROL GROUP WITH 124 PATIENTS WITHOUT LAAO RECEIVING PULMONARY VEIN ISOLATION WERE INCLUDED FOR COMPARISON. THE RATE OF PROCEDURE-RELATED PERICARDIAL EFFUSION WAS SIMILAR BETWEEN THE TWO GROUPS WITH 5 TOTAL. THERE WERE 3 PERIPROCEDURAL STROKES. IN THESE TWO PATIENTS WITH PERIPROCEDURAL STROKE, THE POSSIBILITY THAT THE CATHETER TOUCHED THE OCCLUDER DEVICE AND CAUSED MICROTHROMBUS EMBOLIZATION COULD NOT BE RULED OUT. THEREFORE, IT WAS PROPOSED NOT TO TOUCH THE DEVICE AS MUCH AS POSSIBLE BY USING A COMPUTED TOMOGRAPHY AND 3D MAPPING MERGE TO GUIDE THE EXACT LOCATION OF THE OCCLUDER WHEN ABLATING THE LEFT-SIDED PULMONARY VEIN, OR IN CARTO, THE CT COULD BE USED TO GUIDE THE ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475885 TRANSSEPTAL NEEDLE, BRK SERIES TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other