BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 17936790 · Received October 14, 2023

    Report

    Report Number
    1035166-2023-00114
    Event Type
    Injury
    Date Received
    October 14, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 14, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS PROVIDED FOR ANALYSIS. THERE WAS NO ALLEGATION AGAINST OSCOR'S PRODUCT. THE LOT NUMBER OF THIS DEVICE WAS NOT PROVIDED, THEREFORE NEITHER A REVIEW OF THE DEVICE HISTORY RECORDS, NOR COMPLAINT HISTORY COULD BE PERFORMED. NO FURTHER FOLLOW-UP IS REQUIRED. THE DEVICE WAS NOT RETURNED AND THERE WAS NO SPECIFIC PERFORMANCE RELATED FAILURE REPORTED BY THE USER. BASED ON THE INVESTIGATION, NO CORRECTIVE ACTION IS REQUIRED, NO ALLEGATION WAS REPORTED AGAINST OSCOR'S PRODUCT. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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 AS "AFTER BLEEDING GROIN." ON (B)(6) 2023 CUSTOMER REPORTED THIS EVENT IS "NOT RELATED" TO THIS GUIDESTAR, THE PROCEDURE BEING PERFORMED WAS ATRIAL FIBRILLATION (AFIB). PATIENTS' OUTCOME IS "RECOVERED/RESOLVED." THE ADVERSE EVENT TERM VALVE WAS CHANGED TO "BLEEDING GROIN." ON 13/OCT/2023 CUSTOMER REPORTED THIS PATIENT IS INVOLVED IN A CLINICAL STUDY. LOCATION OF DEVICE NOT PROVIDED. SUBMITTED FOR ADMINISTRATIVE PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969087 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H