BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 24561446 · Received March 10, 2026

    Report

    Report Number
    3008452825-2026-00139
    Event Type
    Injury
    Date Received
    March 10, 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

    ADDITIONAL INFORMATION: B5, 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.

    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.

    Description of Event or Problem · 0

    IN THE CHINESE LITERATURE REVIEW, ONE PUBLICATION STATES THAT: LITERATURE INFORMATION: ZHU XIANGUAN, CHEN LIANGCHUAN, QIAO RUI, ET AL. RETROSPECTIVE STUDY ON THE CLINICAL CHARACTERISTICS OF ST-SEGMENT ELEVATION SECONDARY TO SINGLE- AND DOUBLE-SHEATH TRANSSEPTAL PUNCTURE DURING ATRIAL FIBRILLATION RADIOFREQUENCY ABLATION. AEROSPACE MEDICINE, 2023, 40(04): 327¿330. A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON 1,132 PATIENTS WHO UNDERWENT RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION AT ANQING MUNICIPAL HOSPITAL FROM JANUARY 2008 TO NOVEMBER 2022. AMONG THEM, 589 PATIENTS UNDERWENT SINGLE-SHEATH TRANSSEPTAL PUNCTURE AND 543 PATIENTS UNDERWENT DOUBLE-SHEATH TRANSSEPTAL PUNCTURE. THE INCIDENCE OF ST-SEGMENT ELEVATION AFTER TRANSSEPTAL PUNCTURE, THE SEVERITY OF ASSOCIATED CLINICAL SYMPTOMS (SEVERE, MODERATE, MILD, AND MINIMAL), AS WELL AS THE LOWEST SYSTOLIC BLOOD PRESSURE (SBP), LOWEST DIASTOLIC BLOOD PRESSURE (DBP), LOWEST HEART RATE (HR), AND DURATION OF SYMPTOMS (FOR PATIENTS WHO EXPERIENCED TWO EPISODES OF ST-SEGMENT ELEVATION, THE PARAMETERS WERE RECORDED AT THE TIME OF THE MORE SEVERE SYMPTOMS) WERE COMPARED BETWEEN THE TWO GROUPS. AN EVENT OF ST ELEVATION AFTER TRANSSEPTAL PUNCTURE WAS REPORTED. THE PHYSICIAN CONFIRMED THAT THE BRK NEEDLE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ST ELEVATION. ADDITIONALLY, THERE WAS NO PERFORMANCE ISSUE WITH THE NEEDLE.

    Description of Event or Problem · 0

    IN THE CHINESE LITERATURE REVIEW, ONE PUBLICATION STATES THAT: LITERATURE INFORMATION: ZHU XIANGUAN, CHEN LIANGCHUAN, QIAO RUI, ET AL. RETROSPECTIVE STUDY ON THE CLINICAL CHARACTERISTICS OF ST-SEGMENT ELEVATION SECONDARY TO SINGLE- AND DOUBLE-SHEATH TRANSSEPTAL PUNCTURE DURING ATRIAL FIBRILLATION RADIOFREQUENCY ABLATION. AEROSPACE MEDICINE, 2023, 40(04): 327¿330. A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON 1,132 PATIENTS WHO UNDERWENT RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION AT ANQING MUNICIPAL HOSPITAL FROM JANUARY 2008 TO NOVEMBER 2022. AMONG THEM, 589 PATIENTS UNDERWENT SINGLE-SHEATH TRANSSEPTAL PUNCTURE AND 543 PATIENTS UNDERWENT DOUBLE-SHEATH TRANSSEPTAL PUNCTURE. THE INCIDENCE OF ST-SEGMENT ELEVATION AFTER TRANSSEPTAL PUNCTURE, THE SEVERITY OF ASSOCIATED CLINICAL SYMPTOMS (SEVERE, MODERATE, MILD, AND MINIMAL), AS WELL AS THE LOWEST SYSTOLIC BLOOD PRESSURE (SBP), LOWEST DIASTOLIC BLOOD PRESSURE (DBP), LOWEST HEART RATE (HR), AND DURATION OF SYMPTOMS (FOR PATIENTS WHO EXPERIENCED TWO EPISODES OF ST-SEGMENT ELEVATION, THE PARAMETERS WERE RECORDED AT THE TIME OF THE MORE SEVERE SYMPTOMS) WERE COMPARED BETWEEN THE TWO GROUPS. AN EVENT OF ST ELEVATION AFTER TRANSSEPTAL PUNCTURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616998 TRANSSEPTAL NEEDLE, BRK SERIES TROCAR DRC ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening