BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 1930009 · Received November 19, 2010

    Report

    Report Number
    3008493244-2010-00009
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K102728
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INSPECTION. A CAPA INVESTIGATION HAS BEEN CONDUCTED INTO THE IDENTIFICATION OF A ROOT CAUSE FOR SHEATH DETACHMENTS AND AS A RESULT OF THE INVESTIGATION, ARSTASIS HAS IDENTIFIED A DESIGN IMPROVEMENT, NEW SPECIFICATION AND NEW TEST METHOD THAT ARE INTENDED TO REDUCE THE INCIDENCE OF SHEATH DETACHMENT. THE DESIGN CHANGE WAS REVIEWED BY THE PERIPHERAL VASCULAR DEVICES BRANCH IN THE OFFICE OF DEVICE EVALUATION AS A SPECIAL 510(K) SUBMISSION AND HAS BEEN CLEARED (K102728) ON (B)(6) 2010.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A DIAGNOSTIC PROCEDURE ON A PT WITH HIGHLY DISEASED AND CALCIFIED VESSEL. THE PHYSICIAN STRUGGLED TO ADVANCE THE DEVICE AND WAS SLOWLY ADVANCING BACK AND FORTH TO "MASSAGE" IT INTO THE ARTERY. THE PHYSICIAN PULLED BACK ON THE DEVICE IN AN EFFORT TO REPOSITION IT AND NOTED THAT THE SHEATH SEPARATED FROM THE DEVICE. THE SHEATH WAS ABOVE SKIN LEVEL AND THE PHYSICIAN WAS ABLE TO TAKE IT OUT OF THE PT BY MANUALLY PULLING IT OUT. THE PROCEDURE WAS COMPLETED USING STANDARD METHODS AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARSTASIS ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS, INC. 10F01357

    Patients

    Seq Age Sex Outcome Treatment
    1