BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 15093468 · Received July 25, 2022

    Report

    Report Number
    1035166-2022-00090
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    June 28, 2022
    Report Date
    December 9, 2022
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REPORTED TO OSCOR IN ERROR. ADDITIONAL INFORMATION WAS REPORTED THAT THERE IS NO SPECIFIC COMPLAINT AGAINST THIS GUIDESTAR. THE REPORTED 30 MINUTE DELAY WAS BECAUSE THE OPERATOR WAS INITIALLY RELYING ON CARTO TO POSITION THE BALLOON. AS THERE'S POOR VISUALIZATION, HE ATTEMPTED TO REPOSITION A FEW TIMES; EVENTUALLY HAD TO USE FLUOROSCOPY TO CONFIRM GOOD PLACEMENT. THE DELAY WAS NOT RELATED TO THE GUIDESTAR. NO FURTHER FOLLOW-UP IS REQUIRED. THERE IS NO ALLEGATION THAT THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. 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 A HELIOSTAR EXTERNAL EVALUATION (AF ABLATION) CLINICAL TRAIL, IT WAS REPORTED POOR HELIOSTAR BALLOON VISUALIZATION/ ALIGNMENT WAS SEEN THROUGHOUT THE PROCEDURE. THE CATHETER ALSO KEEPS FLICKING IN AND OUT OF THE LA BODY AND RIGHT-SIDED PVS BUT ON FLUOROSCOPY, THE CATHETER SHOWS IT'S IN A STABLE POSITION. PROCEDURE COMPLETED HOWEVER THE OPERATOR RELIED MORE ON X-RAY INSTEAD OF CARTO TO VERIFY CATHETER POSITION AND STABILITY. ERROR REPORT GENERATED AT THE END OF THE CASE AND PROCEDURE DATA SENT TO R&D FOR FURTHER INVESTIGATION. IT WAS REPORTED THE SURGERY WAS PROLONGED FOR APPROXIMATELY 30 MINUTES. THERE WERE NO PATIENT CONSEQUENCES AND NO DEVICE PERFORMANCE ISSUE REPORTED. NO AVAILABLE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73455 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 DP-15457 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization