BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAIDED SWARTZ 63CM LAMP45

    MDR report key: 16675689 · Received April 4, 2023

    Report

    Report Number
    3005334138-2023-00136
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 30, 2023
    Report Date
    April 28, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 8F SWARTZ BRAIDED INTRODUCER SHEATH WAS RECEIVED FOR EVALUATION. THE SHEATH PASSED PRESSURE AND ASPIRATION LEAK TESTING WITH NO ANOMALIES OBSERVED, BOTH WITH AND WITHOUT AN ADVISOR HD CATHETER INSERTED THROUGH THE HEMOSTASIS VALVE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED LEAK REMAINS UNKNOWN.

    Description of Event or Problem · 0

    DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, A BLOOD LEAK WAS NOTED. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SHEATH WAS INSERTED INTO THE PATIENT, AND THE SEPTAL PUNCTURE WAS PERFORMED WITH THE NON ABBOTT RF NEEDLE JAPAN LIFELINE. THE ADVISOR HDG CATHETER WAS INSERTED BUT IT WAS NOTED THAT BLOOD LEAKED OUT FROM THE HEMOSTATIC VALVE WHILE MAPPING. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL VENIPUNCTURE OR SEPTUM PUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403648 BRAIDED SWARTZ 63CM LAMP45 TRANSSEPTAL CATHETER INTRODUCER DYB ST. JUDE MEDICAL G407372 8540677

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown