BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 16872319 · Received May 4, 2023

    Report

    Report Number
    1035166-2023-00056
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 14, 2023
    Report Date
    November 1, 2023
    Manufacturer
    OSCOR.INC
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    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 REPORT 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.

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER OF THIS DEVICE WAS NOT PROVIDED, THEREFORE NEITHER A REVIEW OF THE DEVICE HISTORY RECORD NOR COMPLAINT HISTORY COULD BE PERFORMED. INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT PASS ALL IN-PROCESS AND QA FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. 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 THAT PATIENT HAD PSEUDO-ANEURYSM RIGHT GROIN. NO PRODUCT MALFUNCTION REPORTED BY CUSTOMER .NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 05/16/2023: PATIENT INFORMATION PROVIDED: PATIENT UNDERWENT ATRIAL FIBRILLATION (AFIB) PROCEDURE. PATIENT WAS HOSPITALIZED FOR 7 DAY AND IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714648 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR.INC D141103 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention| H| L