BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 14141260 · Received April 19, 2022

    Report

    Report Number
    1035166-2022-00054
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    March 22, 2022
    Report Date
    September 6, 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 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

    HELIOSTAR EE - AFTER SHEATH EXCHANGE (SL1 FOR GUIDESTAR), ST ELEVATION WAS OBSERVED ON THE ECG, LEADING AFTER SOME MINUTES TO SEVERAL VF EPISODES. SYSTOLIC BLOOD PRESSURE DROPPED TO 3.5-4 AND A CORONAROGRAPHY WAS PERFORMED. IT SHOWED A POSSIBLE CORONARY SPASM IN THE DESCENDANT ANTERIOR PART OF THE LEFT CORONARY ARTERY. ALSO, THE PATIENT HAD AN ISCHEMIC EPISODE IN THE PAST THAT WAS VISIBLE IN THE CORONAROGRAPHY BUT HAD NOTHING TO DO WITH THIS ADVERSE EVENT AFTER 30-40 MINUTES, ECG CAME BACK TO NORMAL AND BP WAS STABILIZED. AF PROCEDURE WAS SUSPENDED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934957 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141101 C8-19616 00885672009496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization