BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARSTASIS ONE ACCESS SYSTEM

    MDR report key: 2092561 · Received May 3, 2011

    Report

    Report Number
    3008493244-2011-00011
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K102728
    Adverse Event
    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. THE ANALYSIS CONFIRMED THAT THE DEVICE SHEATH WAS SEPARATED FROM THE ANCHOR AT THE COREWIRE. THE INSPECTION ALSO REVEALED THE NEEDLE LUMEN-TO-ANCHOR (NLA) WELD JOINT HAD BENT AND SEPARATED, THERE WAS EVIDENCE OF DAMAGE AT THE SHEATH EXIT PORT AND CLAMP MARKS ON THE SHEATH. DIMENSIONAL INSPECTIONS FOR THE CORE WIRE AND SHEATH WERE FOUND WITHIN SPEC. (B)(4) HISTORY WAS REVIEWED AND NONE HAD BEEN INITIATED RELATED TO THE OBSERVED ISSUES. BASED ON THE ANALYSIS AND THE EVENT DESCRIPTION, THE PROBABLE ROOT CAUSE FOR THE REPORTED SHEATH FRACTURE IS USE ERROR DUE TO OVER MANIPULATION IN TORTUOUS ANATOMY. EXCESSIVE FORCE MAY ALSO HAVE RESULTED IN THE OBSERVED DEVICE FRACTURE AND BEND AT THE NLA WELD, THE DAMAGE AT THE SHEATH EXIT PORT AND ACTUATOR CABLE. IT CANNOT BE DETERMINED WHEN THE OBSERVED DAMAGE AT THE SHEATH EXIT PORT OCCURRED AND A ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED, HOWEVER, IT APPEARS TO BE UNRELATED TO THE REPORTED SHEATH FRACTURE AND FAILURE TO ACHIEVE FIRST MARK. IT IS LIKELY THE CLAMP MARKS ON THE SHEATH OCCURRED DURING REMOVAL OF THE SHEATH FROM THE TISSUE TRACT. BASED ON AVAILABLE INFO, THE PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE TO ACHIEVE FIRST MARK IS TORTUOUS PT ANATOMY. PRECAUTIONS IN THE IFU INSTRUCT TO "AVOID EXCESSIVE ROTATION, BENDING OR KINKING OF THE DEVICE DURING INSERTION AND REMOVAL AS THIS MAY CAUSE DAMAGE OR AFFECT THE PERFORMANCE OF THE DEVICE INCLUDING OBSTRUCTION OF THE NEEDLE LUMEN." THE PHYSICIAN WAS INSTRUCTED TO AVOID OVER MANIPULATION AND EXCESSIVE FORCE WHEN INSERTING THE DEVICE.

    Description of Event or Problem · 1

    THE PHYSICIAN GAINED ACCESS USING A 6F SYSTEM. HE ENCOUNTERED SOME RESISTANCE WHILE INSERTING THE 0.018 WIRE. FLUORO CONFIRMED THAT THE WIRE WAS IN THE ARTERY, THOUGH IT WAS NOTED THAT THE VESSEL WAS TORTUOUS AND CALCIFIED. THE PHYSICIAN DID NOT SUPPRESS THE SUBCUTANEOUS TISSUE WITH HIS HAND AS HE ADVANCED THE DEVICE INTO THE BODY. HE ENCOUNTERED SOME RESISTANCE AND FLIPPED THE ARSTASIS DEVICE OVER SO THAT IT FACED UPWARD AND HE THEN ADVANCED THE DEVICE FURTHER. FIRST MARK WAS NOT ACHIEVED. HE PULLED BACK AND NOTED THAT THE CATHETER HAD DETACHED. THE SHEATH WAS GRASPED AND REMOVED WITH FORCEPS FROM THE SUBCUTANEOUS TISSUE. THERE WAS NO PT INJURY AND ACCESS WAS ACHIEVED THROUGH A STANDARD ARTERIOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARSTASIS ONE ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 10K19468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention