BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 12666729 · Received October 20, 2021

    Report

    Report Number
    3008452825-2021-00501
    Event Type
    Injury
    Date Received
    October 20, 2021
    Report Date
    November 18, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 EFFUSION REMAINS UNKNOWN. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS IDENTIFIED THROUGH A CER LITERATURE SEARCH THAT REPORTS ADVERSE EVENTS IN PROCEDURES WHERE AN ABBOTT DEVICE WAS USED. THE FOLLOWING WAS PUBLISHED IN THE JIJC HEART & VASCULATURE 31 (2020) 100661 IN AN ARTICLE TITLED ¿CATHETER ABLATION FOR ATRIAL FIBRILLATION IN A LOW-VOLUME CENTER USING CONTEMPORARY TECHNOLOGY" BY JULIAN CHEONG KIAT TAY, ET AL., 4 AUGUST 2020. DURING A STUDY OF 71 CONSECUTIVE PATIENTS (50 PAROXYSMAL AF [PAF] VS 21 PERSISTENT AF) WHO UNDERWENT FIRST CATHETER ABLATION, ONE PATIENT DEVELOPED A MODERATE LOCALIZED PERICARDIAL EFFUSION (1.5 CM) ADJACENT TO RIGHT ATRIUM AND VENTRICLE AFTER TRANS-SEPTAL PUNCTURE. NO PERICARDIOCENTESIS WAS PERFORMED AS THE PATIENT WAS HEMODYNAMICALLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560741 TRANSSEPTAL NEEDLE, BRK SERIES TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other