BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 21738252 · Received April 1, 2025

    Report

    Report Number
    3008452825-2025-00145
    Event Type
    Injury
    Date Received
    April 1, 2025
    Report Date
    April 11, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H2, H6, H11. THE BROCKENBROUGH NEEDLE / SHEATH DID NOT CONTRIBUTE DIRECTLY TO THESE COMPLICATIONS. THESE EVENTS WERE DUE TO TECHNICAL CHALLENGES AND COMPLEX CARDIAC ANATOMY.

    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 TAMPONADE / PERFORATION REMAINS UNKNOWN. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE BROCKENBROUGH NEEDLE / SHEATH DID NOT CONTRIBUTE DIRECTLY TO THESE COMPLICATIONS. THESE EVENTS WERE DUE TO TECHNICAL CHALLENGES AND COMPLEX CARDIAC ANATOMY.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN: PACING AND CLINICAL ELECTROPHYSIOLOGY "TRANSSEPTAL PUNCTURE IN CHILDREN WEIGHING LESS THAN 20 KG IN INVASIVE CARDIAC CATHETERIZATION AND ELECTROPHYSIOLOGY "; MERVE MAZE AYDEMI. THIS RETROSPECTIVE STUDY ANALYZED TSP PROCEDURES IN INFANTS AND CHILDREN <20 KG BETWEEN DECEMBER 2015 AND JANUARY 2023. TSPS WERE PERFORMED WITH A BIPLANE ANGIOGRAPHY SYSTEM IN THE CATHETER ANGIOGRAPHY LABORATORY. A BROCKENBROUGH NEEDLE (BRK TRANSSEPTAL NEEDLE; ABBOTT/ST. JUDE MEDICAL, INC.) WAS USED FOR TSP. IN PATIENTS WHOSE BROCKENBROUGH NEEDLES COULD NOT CROSS THE INTERATRIAL SEPTUM, TSP WAS PERFORMED BY APPLYING CAUTERY ENERGY OVER THE BROCKENBROUGH NEEDLE. NINETEEN PATIENTS WERE STUDIED (SEVEN FEMALES, MEDIAN AGE 2.3 YEARS, MEDIAN WEIGHT 10.3 KG), AND 63% REQUIRED TSP FOR CHD. THE CHD GROUP HAD YOUNGER PATIENTS (MEDIAN AGE: 6.25 MONTHS) WITH SMALLER WEIGHTS (MEDIAN: 5.3 KG) THAN THE CATHETER ABLATION GROUP. THERE WAS NO DIFFERENCE BETWEEN GROUPS IN TERMS OF GENDER AND SUCCESS RATES. PROCEDURE AND FLUOROSCOPY TIMES WERE SHORTER IN THE ABLATION GROUP (P < 0.05). AS PERICARDIAL TAMPONADE OCCURRED IN TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172086 TRANSSEPTAL NEEDLE, BRK SERIES TROCAR DRC ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown