BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 14074880 · Received April 11, 2022

    Report

    Report Number
    1035166-2022-00043
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 15, 2022
    Report Date
    August 24, 2022
    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

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1: B4, G1, G3, G6, H2, H6, AND H10: THE DEVICE WAS USED IN TREATMENT AND NOT RETURNED FOR ANALYSIS. THERE IS NO ALLEGATION THAT THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE DEVICE PASS ALL IN-PROCESS AND QA FINAL INSPECTION BEFORE SHIPPING TO THE CUSTOMER. THERE WAS NO REPORTED DEVICE FAILURE IN THIS EVENT. NO FURTHER FOLLOW-UP IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A HELIOSTAR EE PROCEDURE AFTER THE TRANSSEPTAL PUNCTURE, THE ABBOTT FIXED SHEATH (SL1) WAS EXCHANGED BY THE GUIDESTAR 13.5F. JUST AFTER INTRODUCING THE HELIOSTAR BALLOON, ST ELEVATION WAS NOTICED IN THE ECG, FOLLOWED BY APPROXIMATELY 6 EPISODES OF VENTRICULAR FIBRILLATION (10-15 BEATS EACH, MORE OR LESS). CORONARIOGRAPHY WAS PERFORMED, AIR EMBOLISM WAS SUSPECTED BUT NO EVIDENCE FOUND IN THE X-RAY IMAGING. AFTER 15 MINUTES THE ECG WAS NORMAL AGAIN, THE PROCEDURE WAS CONTINUED AND WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339288 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141101 C8-19616 00885672009496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization