BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBLIME¿ RADIAL ACCESS GUIDE SHEATH

    MDR report key: 20700466 · Received November 15, 2024

    Report

    Report Number
    3014687026-2024-00004
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    October 16, 2024
    Report Date
    November 15, 2024
    Manufacturer
    SURMODICS INC
    Product Code
    DYB
    UDI-DI
    05391525785165
    PMA / PMN Number
    FDA PREMARKE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE GUIDE SHEATH WAS USED DURING A LEFT RADIAL ARTERY ACCESS PROCEDURE. DURING REMOVAL OF THE GUIDE SHEATH, THE PATIENT HAD A SIGNIFICANT ARTERIAL SPASM. A VESSEL CUT DOWN AND OTHER REMEDIES WERE REQUIRED TO REMOVE THE SHEATH. THE PROCEDURE DELAY AND OUTCOME WAS UNKNOWN AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037175 SUBLIME¿ RADIAL ACCESS GUIDE SHEATH Introducer, catheter DYB SURMODICS INC SRA-GS35-6F120 22201208 05391525785165

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention