BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 24575103 · Received March 11, 2026

    Report

    Report Number
    3008452825-2026-00145
    Event Type
    Injury
    Date Received
    March 11, 2026
    Report Date
    March 25, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION (D4) AND 510K (G3) ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6, H11. 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. PER THE IFU, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    IN THE CHINESE LITERATURE REVIEW, ONE PUBLICATION STATES THAT: LITERATURE INFORMATION: WU MEIQIONG, LIN YAZHOU, CHEN LIN, ET AL. SAFETY AND EFFICACY OF SECOND-GENERATION CRYOBALLOON ABLATION FOR ATRIAL FIBRILLATION COMBINED WITH HYPERTENSION. FUJIAN MEDICAL JOURNAL, 2024, 46(02): 31¿35. DOI:10.20148/J.FMJ.2024.02.008. A TOTAL OF 1,027 PATIENTS WITH ATRIAL FIBRILLATION WHO UNDERWENT SECOND-GENERATION CRYOBALLOON ABLATION AT FUJIAN PROVINCIAL HOSPITAL WERE INCLUDED. A BRK TRANSSEPTAL PUNCTURE NEEDLE (ABBOTT, USA) WAS USED DURING THE PROCEDURE. EVENTS OF CARDIAC TAMPONADE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635319 TRANSSEPTAL NEEDLE, BRK SERIES TROCAR DRC ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening