BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 17032231 · Received May 31, 2023

    Report

    Report Number
    1035166-2023-00062
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 31, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED IN TREATMENT AND NOT RETURNED FOR ANALYSIS. THERE WAS NO DEVICE PERFORMANCE RELATED FAILURE REPORTED BY THE USER. THIS EVENT IS RELATED TO PATIENT CONDITION. NO FURTHER INVESTIGATION IS REQUIRED. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A DEVICE DEFICIENCY TO A HELIOSTAR, CATALOG NUMBER D138904 WITH SERIAL/LOT NUMBER (B)(6). IT WAS REPORTED THERE WAS A HEMATOMA RIGHT GROIN. THE PATIENT WAS ADMITTED AS IN-PATIENT OR PROLONGED HOSPITALIZED ON (B)(6) 2023 AND DISCHARGED ON (B)(6) 2023. INTERVENTION SPECIFIES COMPRESSION BANDAGE. PATIENT OUTCOME STATES RECOVERED/RESOLVED. IT WAS REPORTED THERE WAS NO LIFE-THREATENING ILLNESS, NOR ANY MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. REPORT STATES GUIDESTAR SHEATH IS NOT RELATED (ANCILLARY DEVICE), THE LOT NUMBER OR MODEL NUMBERS ARE KNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160723 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization