BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 1914310 · Received November 15, 2010

    Report

    Report Number
    3008493244-2010-00008
    Event Type
    Other
    Date Received
    November 15, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    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 NOT RETURNED FOR INSPECTION. 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 SPEC 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 EVAL AS A SPECIAL 510(K) SUBMISSION AND HAS BEEN CLEARED (K102728) OCTOBER 7, 2010.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A PROCEDURE ON AN OBESE FEMALE. THE PHYSICIAN INSERTED THE DEVICE AND THEN PERFORMED A FLUOROSCOPY WHEREUPON HE NOTED THAT THE DEVICE WAS KINKED. THE PHYSICIAN RETRACTED THE DEVICE AND, IN THE PROCESS, THE SHEATH PORTION SEPARATED FROM THE DEVICE. THE PHYSICIAN EXTENDED THE SKIN NICK AND WAS ABLE TO USE A FORCEPS TO RETRIEVE THE SHEATH. THE PROCEDURE COMPLETED AND THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention