BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 1887308 · Received November 1, 2010

    Report

    Report Number
    3008493244-2010-00007
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K100615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INSPECTION; HOWEVER, COMPLETION OF THE INVESTIGATION IS STILL PENDING. A CAPA INVESTIGATION HAS BEEN CONDUCTED INTO THE IDENTIFICATION OF A ROOT CAUSE FOR SHEATH DETACHMENTS AND AS A RESULT OF THE INVESTIGATION ARSTASIS HAS IDENTIFIED A DESIGN IMPROVEMENT, NEW SPECIFICATION AND NEW TEST METHOD THAT ARE INTENDED TO REDUCE THE INCIDENCE OF SHEATH DETACHMENT. THE DESIGN CHANGE WAS REVIEWED BY THE PERIPHERAL VASCULAR DEVICES BRANCH IN THE OFFICE OF DEVICE EVALUATION AS A SPECIAL 510(K) SUBMISSION AND HAS BEEN CLEARED (K102728).

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING AN INTERVENTIONAL PROCEDURE ON A SLENDER PT. THE PHYSICIAN USED A 5F ARSTASIS KIT ON THE RIGHT LEG OF THE PT, IN THE COMMON FEMORAL ARTERY. THE PT RECEIVED 5000MG OF HEPARIN IN THE NORMAL COURSE OF THE PROCEDURE. DEVICE DEPLOYMENT PROCEEDED WITH INCIDENT; HOWEVER, UPON REMOVING THE DEVICE, THE PHYSICIAN ENCOUNTERED DIFFICULTY. THE PHYSICIAN PULLED THE DEVICE OUT AND PART OF THE DEVICE SHEATH WAS MISSING BELOW EXIT PORT. THE PHYSICIAN WAS ABLE TO SNARE THE SHEATH AND REMOVE IT FROM THE LEG. THE INTERVENTION PROCEEDED AS PLANNED. THE PROCEDURAL SHEATH WAS LEFT IN FOR 1 HOUR FOLLOWING THE INTERVENTION. MANUAL COMPRESSION WAS HELD FOR 30 MINUTES. THE PT WAS KEPT ON FLOOR FOR OBSERVATION. THERE WAS NO OBSERVED HEMATOMA AT DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARSTASIS ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS, INC. 10E19356

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention