BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARSTASIS ONE ACCESS SYSTEM

    MDR report key: 2091656 · Received April 28, 2011

    Report

    Report Number
    3008493244-2011-00010
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K102728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INSPECTION AND THERE WERE NO ISSUES REPORTED WITH THE FUNCTIONALITY OF THE DEVICE, THEREFORE DHR REVIEW AND NCMR HISTORY REVIEW WERE NOT PERFORMED. THE EVENT DESCRIPTION DESCRIBES TORTUOUS ANATOMY, LARGE DIAMETER VESSELS AND PT RESTLESSNESS RESULTING IN AN ATTEMPT TO SIT UP WHILE STILL IN RECOVERY. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS OUT OF SPECIFICATION; THE PROBABLE ROOT CAUSE FOR THE REBLEED MAY BE ASSOCIATED WITH PT NON-COMPLIANCE WITH POST OPERATIVE BED REST PROCEDURES.

    Description of Event or Problem · 1

    AFTER HAVING ENCOUNTERED SOME INITIAL DIFFICULTY WIRING, WITH THE .018 WIRE, WHICH KEPT BINDING AND ADVANCING INTO THE ILIAC, THIS DIAGNOSTIC CATHETERIZATION CASE PROCEEDED UNEVENTFULLY. THE PT HAD LARGE (APPROX 12MM) AND TORTUOUS VESSELS. PRESSURE WAS HELD FOR 4 MINS AND THE PT WAS TRANSFERRED TO THE SHORT STAY UNIT FOR RECOVERY. ONE HR LATER, AFTER BLOOD PRESSURE MONITORS SOUNDED, THE PT WAS FOUND TO HAVE REBLED FROM THE ACCESS SITE. THE NURSE AND A SECOND PT IN A NEARBY BED REPORTED THAT THE PT HAD BEEN TRYING TO GET OFF HIS CART POST-OP, BENDING HIS LEGS AND ATTEMPTING TO SIT UP. IT ALSO WAS DETERMINED THAT HE WAS LEFT UNATTENDED FOR APPROX 20 MINS AFTER BEING TAKEN TO THE SHORT STAY UNIT. THE PT REQUIRED ONE UNIT OF BLOOD FOR STABILIZATION AND WAS DOING FINE AT THE END OF THE DAY.

    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