BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENDRA INTRODUCER SHEATH SET

    MDR report key: 3141235 · Received June 3, 2013

    Report

    Report Number
    2015691-2013-20227
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. THE IMPORTANCE OF RETURNING SUSPECT DEVICES WAS EXPLAINED TO THE SITE. DUE TO NO PRODUCT (OR PHOTO) BEING RETURNED FOR EVALUATION, THE REPORTED SHEATH LEAKAGE COULD NOT BE CONFIRMED. AS DEVICE HISTORY RECORD (DHR) REVIEW AND A COMPLAINT HISTORY ANALYSIS DID NOT REVEAL ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE COULD HAVE POTENTIALLY BEEN RELATED TO THE CUSTOMER COMPLAINT. THE MANUFACTURING PROCESS FOR ASCENDRA SHEATHS INCLUDES A 100% VISUAL INSPECTION UNDER MAGNIFICATION FOR DAMAGE, A 100% INSPECTION THAT SHEATH VALVES ARE PLACED PROPERLY AND SEATED FLUSH AGAINST ONE ANOTHER WITH NO VISIBLE DISTORTION. IN ADDITION, THE SHEATH SUB-ASSEMBLY IS ALSO 100% VISUALLY INSPECTED. SEAL COMPONENTS ARE ALSO SAMPLED FOR INSPECTION TO BE FREE OF VOIDS, CRACKS AND MISFILLS. THESE INSPECTIONS MAKE IT HIGHLY UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE COULD HAVE CAUSED A LEAK. AS STATED IN THE COMPLAINT DESCRIPTION, IT IS POSSIBLE THAT THE GUIDEWIRE MAY NOT HAVE BEEN ALIGNED COAXIALLY WITHIN THE SHEATH DURING THE PROCEDURE. THIS CAN CREATE A DISTORTION IN THE SEAL AND ALLOW BLOOD TO LEAK THROUGH THE OPENING. IN THE INSTRUCTIONS FOR USE (IFU), FOLLOWING SHEATH INSERTION THE OPERATOR IS ADVISED TO CONTINUE TO HOLD THE GUIDEWIRE CENTERED RELATIVE TO THE INTRODUCER SHEATH. THE COMPLAINT COULD NOT BE CONFIRMED, AND NO LABELING INADEQUACIES WERE IDENTIFIED. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL THAT OCCURRENCE RATE EXCEEDS CONTROL LIMITS FOR THIS FAILURE MODE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, AFTER INSERTION OF THE ASCENDRA SHEATH DURING A TRANSAPICAL TAVR PROCEDURE, LEAKAGE (PULSATILE FLOW) WAS NOTED FROM THE HEMOSTASIS VALVE. THE MEDICAL TEAM THOUGHT THAT THE GUIDEWIRE MAY NOT HAVE BEEN COAXIAL IN THE SHEATH. THE PATIENT WAS NOT GIVEN BLOOD PRODUCTS/ TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243010 ASCENDRA INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59406940

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR