BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH® II INTRODUCER SET

    MDR report key: 19119083 · Received April 16, 2024

    Report

    Report Number
    1035166-2024-00031
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    December 29, 2023
    Report Date
    July 17, 2024
    Manufacturer
    OSCOR.INC
    Product Code
    DYB
    PMA / PMN Number
    K122084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING RETROSPECTIVE REVIEW WE FIND OUT THAT MDR IS DUPLICATE OF EVENT 1035166-2024-00145. PLEASE VOID FROM YOUR DATA BASE. 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

    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

    DURING RETROSPECTIVE REVIEW WE FIND OUT THAT MDR IS DUPLICATE OF EVENT 1035166-2024-00145. PLEASE VOID FROM YOUR DATA BASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE INNER VALVE DID NOT BREAK WHEN THE INTRODUCER SHEATH WAS BEING SPLIT AND THE PHYSICIAN HAD TO MANUALLY CUT THE VALVE. THE INTRODUCER SHEATH WAS ATTEMPTED/NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925798 SAFESHEATH® II INTRODUCER SET INTRODUCER, CATHETER DYB OSCOR.INC SS7 DP-18031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown