BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

    MDR report key: 17411065 · Received July 27, 2023

    Report

    Report Number
    3008452825-2023-00321
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 13, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    PMA / PMN Number
    K122587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE BRK TRANSSEPTAL NEEDLE WAS RECEIVED FOR EVALUATION. THE BRK NEEDLE HAD BEEN FRACTURED AT ITS DISTAL END. THE BRK NEEDLE INSTRUCTIONS FOR USE STATE ¿DO NOT ALTER THIS DEVICE IN ANY WAY¿. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE NEEDLE FRACTURE IS CONSISTENT WITH NOT FOLLOWING THE INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, ANALYSIS CONFIRMED THE LOT NUMBER OF THE DEVICE TO BE 9050029.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION PROCEDURE, DURING TRANSSEPTAL PUNCTURE IT WAS NOTED THAT THE DISTAL PART OF THE NEEDLE WAS BROKEN. AFTER MULTIPLE ATTEMPTS TO INSERT THE NEEDLE THE DISTAL PART OF THE NEEDLE WAS NOTED TO BE ON THE PREP TABLE. THERE WERE NO ADVERSE PATIENT HEALTH CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334407 BRK¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL G407208 9050029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown