BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 24714297 · Received March 30, 2026

    Report

    Report Number
    1035166-2026-00015
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 27, 2026
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    PMA / PMN Number
    K151951
    Adverse Event
    Yes
    Product Problem
    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. 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

    COMPETITOR'S INTRODUCER JAMMED IN GUIDESTAR SHEATH, ALLOWING AIR INTRUSION DURING TRIAL. SURGERY WAS DELAYED FOR 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777132 BIOSENSE WEBSTER GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D-1433-01-SI PQOC9173445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H