BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 16856472 · Received May 2, 2023

    Report

    Report Number
    1035166-2023-00055
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 7, 2023
    Report Date
    August 23, 2023
    Manufacturer
    OSCOR.INC
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT 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

    DURING A HELIOSTAR PROCEDURE FOR PULMONARY VEIN ISOLATION, THE SEPTUM WAS PUNCTURED WITH AN 8.5FR BIOSENSE WEBSTER CARDIAGUIDE SHEATH. SUBSEQUENTLY, THE 14FR BIOSENSE WEBSTER GUIDESTAR SHEATH WAS PASSED INTO THE LEFT ATRIUM. CONTRAST WAS USED TO VISUALIZE THE LEFT SUPERIOR PULMONARY VEIN VIA A PIG TAIL CATHETER. AFTER IMAGING, A PROMINENT ST ELEVATION WAS NOTED. BECAUSE OF THE ST ELEVATION, THE PATIENT WAS IMMEDIATELY GIVEN NITRO AND VOLUME. DIRECT ANGIOGRAPHY REVEALED AN UNDETERMINED AMOUNT OF AIR IN THE RIGHT CORONARY ARTERY AND AORTIC ARCH (A. ASCENDERS). THE AIR WAS ASPIRATED AS BEST AS POSSIBLE. THE PATIENT WAS THEN TAKEN TO A COMPUTER TOMOGRAPH FOR FURTHER DIAGNOSIS. AT THE TIME OF THE PROCEDURE NO NEUROLOGIC SYMPTOMS WERE DETERMINED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799698 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR.INC D141103 DP-16445 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown