BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SL SERIES, SL0¿ 10F

    MDR report key: 6873643 · Received September 18, 2017

    Report

    Report Number
    3005334138-2017-00153
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    August 22, 2017
    Report Date
    September 29, 2017
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE SHEATH PASSED PRESSURE AND ASPIRATION LEAK TESTING WITH NO ANOMALIES OBSERVED. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES AS SUPPORTED BY A REVIEW OF THE DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED AIR LEAK REMAINS UNKNOWN AS THE EVENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    DURING AN ELECTROPHYSIOLOGY PROCEDURE FOLLOWING TRANSSEPTAL PUNCTURE, AIR WAS NOTED IN THE INTRODUCER DURING INSERTION OF A MAPPING CATHETER. THERE WAS NO AIR VISUALIZED IN THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITHOUT CONTINUED USE OF THE INTRODUCER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653928 FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SL SERIES, SL0¿ 10F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 406968 5984529

    Patients

    Seq Age Sex Outcome Treatment
    1