BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 4102721 · Received August 28, 2014

    Report

    Report Number
    3008493244-2014-00025
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K140201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT FAILURE ANALYSIS WAS NOT POSSIBLE. 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. DURING MANUFACTURING OF THE LOT, THE HEEL IS 100% VERIFIED TO BE IN ITS PROPER POSITION. THE AXERA 2 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU) WAS REVIEWED. PER THE DEPLOYING THE AXERA ACCESS DEVICE SECTION, "MAKE SURE THAT THE TOP SURFACE OF THE AXERA ACCESS DEVICE FACES UPWARD, AWAY FROM THE SKIN SURFACE." AND "IF THE HEEL IS PREMATURELY DEPLOYED, DO NOT ADVANCE THE DEVICE. RETURN ACTUATOR TO THE RELEASED POSITION, REMOVE AND DISCARD THE DEVICE." ADDITIONALLY, "IF RESISTANCE IS FELT DURING REMOVAL, STOP AND EXAMINE THE AXERA ACCESS DEVICE. VERIFY THAT THE PLUNGER WAS FULLY RETRACTED, AND THE ACTUATOR IS FULLY DISENGAGED. IF RESISTANCE IS STILL FELT, REMOVE THE GUIDEWIRE AND THEN THE AXERA ACCESS DEVICE." THE IFU PROVIDES THE APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNINGS AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. BASED ON THE REVIEW COMPLETED, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS OUT OF SPECIFICATION. THE PROBABLE ROOT CAUSE FOR THE REPORTED DEVICE FRACTURE, BASED ON AVAILABLE INFO, IS REMOVAL OF THE DEVICE AGAINST RESISTANCE. THE PHYSICIAN HAS BEEN RE-TRAINED ON PROPER USAGE OF THE DEVICE, INCLUDING INSTRUCTIONS RELATED TO DEVICE REMOVAL WHEN RESISTANCE IS ENCOUNTERED.

    Description of Event or Problem · 1

    THIS WAS A DIAGNOSTIC CASE. THE PT WAS OBESE AND NO TORTUOSITY, SCARRING, OR CALCIFICATION WERE NOTED WHEN THE PHYSICIAN CONNECTED THE LATCHWIRE TO THE BODY OF THE DEVICE, HE NOTED THAT THE HEEL WAS RELEASED AND OUTSIDE THE DEVICE BODY. HE ATTEMPTED TO PLACE THE HEEL BACK INTO THE DEVICE BODY WITHOUT SUCCESS. THE PHYSICIAN THEN INSERTED THE DEVICE UPSIDE DOWN IN THE ATTEMPT TO KEEP THE HEEL IN THE PROCEDURE PROCEEDED AS PLANNED UNTIL AFTER THE HEEL WAS RELEASED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, BUT ENCOUNTERED RESISTANCE. HE RESET THE HEEL ACTUATOR SEVERAL TIMES, BUT STILL ENCOUNTERED RESISTANCE AND PROCEEDED TO REMOVE THE DEVICE. THERE WAS NO BLEEDING, BUT THE HEEL BROKE OFF OUTSIDE THE BODY. THE PHYSICIAN WAS ABLE TO COMPLETE THE AXERA PROCEDURE AND A 6F SHEATH WAS PLACED. THE PT WAS DISCHARGED THE DAY OF THE PROCEDURE AND RECOVERED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526438 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 14C18045

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 6F SHEATH