BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH II 9F

    MDR report key: 15198510 · Received August 10, 2022

    Report

    Report Number
    1035166-2022-00095
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 11, 2022
    Report Date
    January 5, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    30891492002259
    PMA / PMN Number
    K122084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTION WAS CORRECTED: G4: K122084. THE DEVICE WAS USED IN TREATMENT. THE DEVICE WAS DISCARDED AND NOT RETURNED FOR ANALYSIS. THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. HOWEVER, THE FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED PRODUCT ISSUE. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. PER PROCEDURE, ADELANTE-S INTRODUCER SHEATH IN PROCESS AND FINAL INSPECTIONS DESTRUCTIVE TESTING SAMPLING PLAN ANSI Z 1.4, SPECIAL LEVEL 4, AQL 0.40 REDUCED BREAK AND PEEL TEST USING SAMPLES FROM FIT CHECK AS DESCRIBED IN PROCEDURE. MANUALLY BREAK THE SHEATH AND HUB AND VERIFY THAT THE SEAL SPLITS EASILY WITHOUT EXTREME ELONGATION. ALSO VERIFY THAT THE SPLIT CAP AND SEAL REMAIN SECURE AND DO NOT BREAK FREE OR LOOSEN FROM THE SHEATH HUB. MANUALLY PEEL THE SHEATH AND VERIFY THE SHEATH PEELS EASILY ALONG THE SHEATH BODY AND TIP. THE INSTRUCTIONS FOR USE (IFU) ADELANTE SAFESHEATH II, INFORMS THE USER: FLUSH SHEATH WITH 5CC OF SALINE IMMEDIATELY BEFORE PEELING SHEATH AWAY IN ORDER TO MINIMIZE BACK BLEEDING. WITHDRAW SHEATH AND VALVE OVER THE LEAD OR CATHETER AND FROM THE VESSEL, WHILE KEEPING THE LEAD IN PLACE. SHARPLY SNAP THE TABS OF VALVE HOUSING IN A PLANE PERPENDICULAR TO THE LONG AXIS OF THE SHEATH TO SPLIT THE VALVE AND PEEL SHEATH APART WHILE WITHDRAWING FROM THE VESSEL. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. IN ADDITION, THERE WAS NO NEW FAILURE MODE IDENTIFIED AND THE RISK REMAINS ACCEPTABLE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. 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

    IT WAS REPORTED THAT THE INTRODUCER DID NOT PEEL COMPLETELY. PHYSICIAN HAD TO USE A SCALPEL TO REMOVE PART THAT WASN'T PEELED. THE PATIENT A 75 YEAR OLD FEMALE WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211170 SAFESHEATH II 9F INTRODUCER, CATHETER DYB OSCOR INC. SS9 DP-14348 30891492002259

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female