BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3180259 · Received June 13, 2013

    Report

    Report Number
    3008493244-2013-00027
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K123618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND FAILURE ANALYSIS PERFORMED. EXAMINATION OF THE DEVICE CONFIRMED THE NARRATIVE OF THE COMPLAINT. THE LATCHING COMPONENTS WERE DAMAGED, SPECIFICALLY, THE TAB WAS PARTIALLY STRAIGHTENED AND STRESS MARKS WERE FOUND ON THE TAB. THE LATCH ITSELF WAS UNDAMAGED. THE LATCHWIRE WAS ALSO DAMAGED (KINKED, COIL STRETCHED, DAMAGED CORE WIRE). THE NLA WAS OBSERVED TO BE BENT. THE OBSERVED LATCHWIRE AND NLA ISSUES LIKELY OCCURRED WHEN RESISTANCE WAS ENCOUNTERED DURING INSERTION AND/OR FOLLOWING THE PROCEDURE WHEN AN ATTEMPT TO RE-CREATE THE FAILURE MODE WAS MADE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS LOT AND NO NONCONFORMING MATERIAL REPORTS HAVE BEEN INITIATED THAT ARE RELATED TO THIS FAILURE MODE. THE AXERA 2 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU), WAS REVIEWED. THE IFU PROVIDES THE FOLLOWING PRECAUTION, "AVOID EXCESSIVE ROTATION, BENDING OR KINKING OF THE AXERA ACCESS DEVICE DURING INSERTION AND REMOVAL AS THIS MAY CAUSE DAMAGE OR AFFECT THE PERFORMANCE OF THE DEVICE INCLUDING OBSTRUCTION OF THE NEEDLE LUMEN." NO UPDATE OF THE IFU IS REQUIRED. BASED ON THE ANALYSIS COMPLETED TO DATE, THE LATCHWIRE APPEARS TO HAVE SEPARATED FROM THE DEVICE BECAUSE THE TAB MAY HAVE BEEN DAMAGED (STRAIGHTENED) DURING USE. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN OPENED TO CONTINUE THE INVESTIGATION INTO THIS EVENT.

    Description of Event or Problem · 1

    THIS WAS A PERIPHERAL INTERVENTION. THE PATIENT HAD MINOR SCAR TISSUE AND MILD CALCIFICATION IN RIGHT FEMORAL ARTERY. THE PHYSICIAN INSERTED THE LATCHWIRE (LW), ATTACHED THE DEVICE AND PERFORMED THE TUG TEST. HE HAD DIFFICULTY INSERTING AND ADVANCING THE DEVICE DUE TO IT CATCHING ON STENOSIS. THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE LW. USING FLUOROSCOPY HE ATTEMPTED TO ADVANCE THE DEVICE UP THE ILIAC ARTERY, USING THE HANDLE TO STEER THE LW. THE DISTAL TIP OF THE LW CURLED AND HE PULLED BACK THE DEVICE, ROTATING IT TO TRAVERSE THE TORTUOSITY. HE CHECKED THAT THE LW WAS ATTACHED AND ADVANCED THE DEVICE INTO THE AORTA. ACHIEVED FIRST MARK, HE DEPLOYED THE HEEL, PULLED BACK, PLUNGED, ACHIEVED SECOND MARK. AFTER PLACING THE GUIDEWIRE HE PULLED EVERYTHING OUT AND NOTED THAT THE LW WAS NOT ATTACHED TO THE DEVICE, BUT WAS PROTRUDING AT SKIN LEVEL. HE MANUALLY REMOVED THE LATCHWIRE, AND INSERTED A SHEATH OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. FOLLOWING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY ATTACH THE LATCHWIRE TO THE DEVICE ON A SIDE TABLE. HE PULLED AGGRESSIVELY UNTIL THE LW COIL UNRAVELED TO TEST THE LATCH WHICH REMAINED SECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270275 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 13C27028

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR