BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8.5F DIREX STEERABLE SHEATH

    MDR report key: 8588212 · Received May 7, 2019

    Report

    Report Number
    1035166-2019-00043
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 23, 2019
    Report Date
    June 28, 2019
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    PMA / PMN Number
    K120459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED FOR TREATMENT. ONE DIREX 8.5F INTRODUCER SHEATH WAS RECEIVED BACK FROM THE CUSTOMER WITHOUT THE DILATOR. THERE WERE NO OTHER ACCESSORIES. BLOOD WAS FOUND ON AND INSIDE THE SHEATH. THE HEMOSTASIS VALVE WAS TORN AND HAS A VISIBLE HOLE. UPON EVALUATION OF THE RETURNED SHEATH UNDER A 10X MICROSCOPE, IT WAS FOUND THAT THE INSERTION POINT OF THE DEVICE INTO THE HEMOSTASIS VALVE WAS IDENTIFIED TO BE CONSIDERABLY OFF CENTER OF THE HELICAL CUTS, CREATING A TEAR IN THE VALVE. A LEAK TEST WAS PERFORMED AND THE SHEATH EXHIBITED LEAKAGE COMING FROM THE HOLE IN THE HEMOSTASIS VALVE. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN PROCESS AND FINAL INSPECTIONS. THE TEAR IN THE VALVE DUE TO CONSIDERABLY OFF-CENTER PUNCTURE, RESULTED IN THE LEAKAGE. THE SHEATH PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER INCLUDING VISUAL, DIMENSIONAL AND LEAK TESTING. NO MANUFACTURING DEFECTS WERE FOUND. PER QA STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION PROCEDURE: LEAK TEST: PERFORM LEAK TEST ACCORDING TO PROCEDURE. THE LEAK TEST IS PERFORMED BY MANUFACTURING PERSONNEL AND IS OBSERVED BY QUALITY ASSURANCE PERSONNEL. THIS PROCEDURE IS PERFORMED ON 100% OF THE SHEATHS. AS STATED IN THE INSTRUCTIONS FOR USE (IFU): ANY DEVICE/COMPONENT INSERTED THROUGH THE HEMOSTATIC VALVE OF THE SHEATH SHOULD BE WET AND PLACED THROUGH THE CENTER OF THE VALVE TO PREVENT TEARING OF THE SEAL AND LEAKAGE. 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

    BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE. 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 · 1

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING AN AF PROCEDURE AND ONCE THE TRANSEPTAL WAS COMPLETED, THE DIREX WAS ADVANCED TO THE LA. THE DIREX WAS FLUSHED THREE TIMES AND CHECKED FOR NO BUBBLES. THE ORION WAS THEN INTRODUCED THROUGH THE DIREX AND THE PATIENT EXPERIENCED AN ST ELEVATION. NITRO WAS GIVEN TO THE PATIENT AND THE ST ELEVATION WAS RESOLVED AFTER 4-5 MINUTES. PHYSICIAN STATES THAT THE CAUSE FOR THE ST ELEVATION COULD HAVE BEEN SOME BUBBLES REMAINING INSIDE THE DIREX (AIR EMBOLISM). THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380458 8.5F DIREX STEERABLE SHEATH INTRODUCER, CATHETER DYB OSCOR INC. M004DS300 C8-15910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention