BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 15405153 · Received September 12, 2022

    Report

    Report Number
    1035166-2022-00103
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 26, 2022
    Report Date
    February 9, 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

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. B4, B5, D9, G3, H2, H3, H10 & H11. CORRECTION: THIS IS A NON-REPORTABLE EVENT. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, THERE WAS A LEAK IN THE SIDE ARM TUBING OF THE HELIOSTAR BALLOON CATHETER. THERE WERE NO REPORTED ISSUES WITH THE GUIDESTAR SHEATH. NO LEAKAGE WAS FOUND ANYWHERE ON THE GUIDESTAR SHEATH WHILE PERFORMING A MANUAL LEAK TEST. NO PHYSICAL DAMAGE WAS FOUND ANYWHERE ON THE SHEATH DURING VISUAL INSPECTION AND THE SHEATH DEFLECTED AS INTENDED. 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.

    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

    CLARIFICATION PROVIDED OF COMPLAINT: IT WAS A PRODUCT MALFUNCTION AND THE PRODUCT WAS NOT INSERTED INTO THE PATIENT OR USED. IT WAS A LEAK IN THE SIDE ARM TUBING ON THE HELIOSTAR BALLOON.

    Description of Event or Problem · 0

    TUBING WHERE YOU FLUSH THE SHEATH HAD A HOLE IN IT. LEAKED WHEN FLUSHING. CLARIFICATION PROVIDED OF COMPLAINT: IT WAS A PRODUCT MALFUNCTION AND THE PRODUCT WAS NOT INSERTED INTO THE PATIENT OR USED. IT WAS A LEAK IN THE SIDE ARM TUBING ON THE HELIOSTAR BALLOON. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969301 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 DP-15886 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown