BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.

    MDR report key: 14458707 · Received May 20, 2022

    Report

    Report Number
    3005334138-2022-00334
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    January 18, 2022
    Report Date
    May 19, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 WITHDRAWAL DIFFICULTY AND SUBSEQUENT PUNCTURE TO THE SHEATH COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    2030404-2022-00004. THIS REPORT IS BASED ON INVESTIGATION FINDINGS OF A PIECE OF THE SHEATH THAT WAS STUCK TO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582955 FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8. INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 406849

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown INQUIRY¿ AFOCUS LL¿ DIAGNOSTIC CATHETER