BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFESHEATH® II

    MDR report key: 16855063 · Received May 2, 2023

    Report

    Report Number
    1035166-2023-00047
    Event Type
    Death
    Date Received
    May 2, 2023
    Date of Event
    March 25, 2023
    Report Date
    October 25, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    30891492002259
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PRODUCT PERFORMANCE ISSUE REPORTED. THE PROCEDURE WAS COMPLETED; HOWEVER, DUE TO PATIENT COMPLICATIONS THE PATIENT DIED. NO FURTHER INVESTIGATION 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.

    Additional Manufacturer Narrative · 0

    CORRECTIONS: B3, B4 INFORMATION MISSING FROM INITIAL SUBMISSION. THERE WAS NO REPORTED DEVICE FAILURE IN THIS EVENT. THE EVENT IS RELATED TO THE PATIENT'S EXISTING CONDITION, WHICH DURING AN IMPLANT PROCEDURE THERE WERE DIFFICULTIES IN USING THE FIRST INTRODUCER (13CM) DUE TO PATIENT ANATOMY. AFTER THE IMPLANT PROCEDURE WAS COMPLETED, THE PATIENT HAD SYMPTOMS AND WAS TAKEN TO CARDIAC SURGERY WHERE A SUBCLAVIAN VEIN LACERATION WAS DISCOVERED. THE LACERATION WAS STITCHED UP; HOWEVER, THE PATIENT DIED FOLLOWING THE PROCEDURE. PATIENT DEATH WAS ON (B)(6) 2023. 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 THAT DURING AN IMPLANT PROCEDURE THERE WERE DIFFICULTIES IN USING THE FIRST INTRODUCER (13CM) DUE TO PATIENT ANATOMY. A DIFFERENT LONGER INTRODUCER WAS USED (23CM) AND ABLE TO PASS THE SUBCLAVIAN ANGLE. THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE IMPLANT THE PATIENT HAD SYMPTOMS AND WAS TAKEN TO CARDIAC SURGERY WHERE A SUBCLAVIAN VEIN LACERATION WAS DISCOVERED. THE LACERATION WAS STITCHED UP. THE PATIENT DIED FOLLOWING THE PROCEDURE. THE DEVICE WAS DISCARDED. PATIENT DEATH WAS ON (B)(6) 2023. CAUSE OF THE PATIENT DEATH IS UNKNOWN. OTHER EVENT RELATED TO THE ISSUE REPORTED: 1035166-2023-00049 ADDRESSES THE 23CM INTRODUCER (SAME PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144099 SAFESHEATH® II INTRODUCER, CATHETER DYB OSCOR INC. SS9 DP-17212 30891492002259

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D| L| H