BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 2001125 · Received February 17, 2011

    Report

    Report Number
    3008493244-2011-00002
    Event Type
    Other
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K102728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EXAM. THE EXAM CONFIRMED THAT THE SHEATH WAS SEPARATED FROM THE ANCHOR AT THE COREWIRE, WHICH IS CONSISTENT WITH THE EVENT DESCRIPTION. THE DESCRIPTION OF THE EVENT SUGGESTS THAT EXCESSIVE FORCE WAS USED TO INSERT THE DEVICE. STEP 8 OF THE PRECAUTION SECTION OF THE INSTRUCTIONS FOR USE CAUTIONS THE OPERATOR TO "AVOID EXCESSIVE ROTATION, BENDING OR KINKING OF THE DEVICE DURING INSERTION AND REMOVAL AS THIS MAY CAUSE DAMAGE..." THE OPERATOR WAS RETRAINED.

    Description of Event or Problem · 1

    WHEN INSERTING THE DEVICE THE PHYSICIAN ENCOUNTERED RESISTANCE. THE PHYSICIAN CONTINUED TO PUSH AND TWIST THE DEVICE AS HE TRIED TO ADVANCE IT INTO THE VESSEL AND THEN NOTICED THAT THE DISTAL SHEATH HAD SEPARATED FROM THE ANCHOR. THE DEVICE WAS REMOVED, A 6F SHEATH INSERTED AND A SNARE USED TO PULL OUT THE DEVICE SHEATH THAT WAS INSIDE THE VESSEL. THE DEVICE SHEATH WAS REMOVED SUCCESSFULLY AND A SECOND DEVICE WAS SUCCESSFULLY USED TO ACCESS THE FEMORAL ARTERY. THE PT WAS SUCCESSFULLY TREATED WITH "MINIMAL EFFECT TO THE GROIN", PER THE ARSTASIS REP WHO ATTENDED THE CASE. THE PT RECOVERED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARSTASIS ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS, INC. 10J28456

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention