BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 23594039 · Received November 19, 2025

    Report

    Report Number
    1035166-2025-00055
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 19, 2025
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010270
    PMA / PMN Number
    K151951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. 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

    CUSTOMER REPORTED THIS EVENT IS "NOT RELATED" TO THE STUDY CATHETER (GUIDESTAR IS NOT PART OF A DEVICE DEFICIENCY). PATIENT HOSPITALIZED, ADMISSION DATE (B)(6) 2025 AND DISCHARGE DATE (B)(6) 2025. ADVERSE EFFECT EXPECTED, ANTICIPATED. PATIENTS' OUTCOME RECOVERED, RESOLVED, END DATE (B)(6) 2025. NO REPEAT ABLATION, NO SURGERY, LEAVE STITCH IN SITU, MANUAL PRESSURE APPLIED, CONTINUE OBSERVATION. FOR THIS PARTICULAR EVENT, IT IS AN EXPECTED SAE AND UNRELATED TO A DEVICE DEFICIENCY. THERE WAS NO INTERVENTION, NO MEDICATION AND IS CURRENTLY RESOLVED. SUBMITTED FOR ADMINISTRATIVE PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2883055 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D-1433-01-SI PQOC9228875 00885672010270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization