BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESTINO¿ REACH STEERABLE GUIDING SHEATH

    MDR report key: 23535300 · Received November 12, 2025

    Report

    Report Number
    1035166-2025-00052
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 12, 2025
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672007553
    PMA / PMN Number
    K151951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    THE REPORTED EVENT OCCURRED DURING THE PREPARATION AND DURING ENDOVASCULAR AORTIC REPAIR PROCEDURE. THERE WAS A TOTAL OF FIVE DESTINO REACH SHEATHS USED AT THIS PROCEDURE. TWO SHEATHS WITH DEFLECTION ISSUES OCCURRED DURING PREPARATION, IT WAS NOTICED THAT THE FRONT PART OF THE HANDLE COULD NOT BE ROTATED. EVEN WITH INCREASED FORCE, THE FRONT PART OF THE HANDLE COULD NOT BE TURNED TO ENABLE DEFLECTION. TWO MORE SHEATHS WERE USED, THERE WERE PASSAGE ISSUES WITH THEM. THE DILATOR AND GUIDEWIRE COULD BE INSERTED, BUT EVEN A STANDARD 5F CATHETER ENCOUNTERED RESISTANCE. ONE ADDITIONAL 5F SHEATH (BRAND, MODEL UNKNOWN) COULD NOT BE INSERTED AT ALL. IT WAS FOUND THAT THE TIP OF THE DILATOR WAS FRAYED. THE OBSTRUCTION WAS LOCATED AT THE LEVEL OF THE FRONT PART OF THE HANDLE. (REFERENCE 1035166-2025-00053). IT WAS REPORTED THE SHEATHS WERE TESTED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) DURING PREPARATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A FIFTH DESTINO REACH. NO PATIENT HARM WAS REPORTED, HOWEVER, THERE WAS AN APPROXIMATE 90-MINUTE PROCEDURE DELAY. NO PICTURES, IMAGES, OR VIDEOS ARE AVAILABLE OF THE MALFUNCTION. IT IS UNKNOWN IF THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, OR OBESE, AND IT IS NOT KNOWN IF DEVICES WERE USED IN A TORTUOUS PATH WHEN THE EVENT OCCURRED. THE FOUR DESTINO REACH SHEATHS WERE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544133 DESTINO¿ REACH STEERABLE GUIDING SHEATH DESTINO¿ REACH STEERABLE GUIDING SHEATH DYB OSCOR INC. DCR0856717 00885672007553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization