BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR STEERABLE GUIDING SHEATH

    MDR report key: 10819552 · Received November 10, 2020

    Report

    Report Number
    1035166-2020-00073
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    September 16, 2020
    Report Date
    March 23, 2021
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672009496
    PMA / PMN Number
    K140406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP. THE DEVICE WAS USED IN TREATMENT AND NOT RETURNED FOR ANALYSIS. THERE WAS NO SPECIFIC PERFORMANCE RELATED FAILURE REPORTED BY THE USER. ACCORDING TO THE USER, TRANSSEPTAL PUNCTURE AND SHEATH POSITIONING INTO THE LA MIGHT DETERMINE CORONARY SPASM AND TRANSIENT ST ELEVATION. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE INVESTIGATION, A CAPA IS NOT 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 · 1

    OUR INVESTIGATION IS STILL IN PROGRESS, FOLLOW UP REPORT WILL BE SUBMITTED IF WE FIND ANY FURTHER ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER PLACING GUIDESTAR STEERABLE SHEATH INTO THE LEFT ATRIUM THE TRANSIENT ST ELEVATION HAPPENED. MEDICATION REQUIRED TO TREAT ST ELEVATION. CAUSE OF THE ST ELEVATION IS UNKNOWN. NO OTHER PATIENT SIDE EFFECTS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281822 GUIDESTAR STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141101 OR-04983 00885672009496

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention