BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 16248873 · Received January 26, 2023

    Report

    Report Number
    1035166-2023-00012
    Event Type
    Death
    Date Received
    January 26, 2023
    Date of Event
    November 28, 2022
    Report Date
    August 1, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, HOWEVER, INSPECTION PROCEDURES REQUIRE ANY OSCOR PRODUCT TO PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THERE WAS NO DEVICE PERFORMANCE ISSUE REPORTED, SO NO INVESTIGATION IS REQUIRED. MULTIPLE ATTEMPTS TO OBTAIN CLARIFICATION WERE MADE, HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE 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.

    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

    AN ADVERSE EVENT HAS BEEN REPORTED. IT'S STATED ON THE (B)(6) 2022, DURING PULMONARY VEIN ISOLATION (PVI), A HELIOSTAR BALLOON CATHETER WAS USED. THE PATIENT DIED ON THE (B)(6) 2022, FROM FISTULA BETWEEN THE LEFT ATRIUM OF THE HEART AND ESOPHAGUS. IT'S STATED A TEMPERATURE PROBE WAS USED IN THE ESOPHAGUS. DURING THE ABLATION THE TEMPERATURE RISE WAS NOTICED ON THE TEMPERATURE PROBE, AND THE CORRESPONDING ELECTRODE ON THE POSTERIOR WALL, WAS SWITCHED OFF AT 36 SEC OF THE ABLATION. THE TEMPERATURE WAS NOTED AS 48 DEGREES CELSIUS. CATHETER USED: HELIOSTAR LASSO STAR NAV CS CATHETER GUIDESTAR SHEATH CASE COMPLETED. THERE WERE NO PATIENT CONSEQUENCES NOTICED AND THERE WAS NO DELAY. SUBMISSION FOR ADMINISTRATIVE PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942814 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death