BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 2823558 · Received September 10, 2010

    Report

    Report Number
    3008493244-2010-00001
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K100615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INSPECTION. DEVICE ANALYSIS CONSISTED OF A REVIEW OF LOT HISTORY RECORDS (LHR) AND THE EVENT DESCRIPTION. LOT HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS RELATED TO THE COMPLAINT. COMPLAINT HISTORY FOR ALL ARSTASIS PRODUCT WAS REVIEWED, THIS IS THE FIRST REPORT OF THIS KIND. BASED ON THE ANALYSIS COMPLETED, THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPEC. SUSPECT ROOT CAUSE FOR INABILITY TO STOP MARK IS THAT THE DEVICE WAS NOT PROPERLY POSITIONED AGAINST THE ARTERY WALL, PERHAPS DUE TO AN ANATOMICAL FEATURE. THE PHYSICIAN USED EXCESSIVE FORCE WHEN PULLING THE DEVICE BACK TO STOP MARK, WHICH ENLARGED THE ARTERIOTOMY. ADDITIONALLY, THE DELAY IN APPLYING COMPRESSION IMMEDIATELY RESULTED IN THE LARGE HEMATOMA. BLEEDING WAS STOPPED USING MANUAL COMPRESSION. THE PT RECEIVED THE PRESCRIBED TREATMENT, DELAYED BY ONE DAY, WITH NO FURTHER INCIDENT.

    Description of Event or Problem · 1

    PROCEDURE DELAY DUE TO LARGE HEMATOMA. THIS EVENT OCCURRED DURING PHYSICIAN'S INITIAL USE OF THE ARSTASIS DEVICE, AN ARSTASIS REP WAS PRESENT DURING THE CASE. THE PHYSICIAN PERFORMED A DIAGNOSTIC CATHETERIZATION PROCEDURE ON A LARGE FEMALE PT. THE PHYSICIAN INSERTED THE ARSTASIS DEVICE, AND OBSERVED MARK. HE ACTUATED THE HEEL, PULLED BACK AND CONTINUED TO SEE BLOOD FLOW THROUGH THE MARKER PORT. THE PHYSICIAN PULLED BACK FURTHER AND THE DEVICE EXITED THE ARTERY WITH THE HEEL DEPLOYED. A SHORT AMOUNT OF TIME ELAPSED BEFORE HE APPLIED PRESSURE TO STEM THE FLOW. A HEMATOMA FORMED AT THE SITE, APPROX THE SIZE OF A HAND FROM WRIST TO FINGERTIP. THE DIAGNOSTIC RIGHT CATHETERIZATION PROCEDURE WAS COMPLETED THROUGH A VENOUS SHEATH AND THE PT WAS BROUGHT BACK TO HER ROOM TO FURTHER MANAGE THE HEMATOMA WITH MANUAL COMPRESSION. THE PLANNED LEFT HEART CATHETERIZATION WAS POSTPONED TO THE FOLLOWING DAY AND WAS PERFORMED THROUGH THE CONTRA-LATERAL SIDE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARSTASIS ACCESS SYSTEM CATHETER INTRODUCER DYB ARSTASIS INC. 10F03359

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention