BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARSTASIS ACCESS SYSTEM

    MDR report key: 1914436 · Received November 22, 2010

    Report

    Report Number
    3008493244-2010-00010
    Event Type
    Other
    Date Received
    November 22, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K102728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 (B)(4) AS A SPECIAL 510 (K) SUBMISSION AND HAS BEEN CLEARED (K102728). (B)(4) 2010.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING A PROCEDURE USING A 6F ARSTASIS KIT. AS THE PHYSICIAN ADVANCED THE GUIDEWIRE HE REPORTEDLY FELT RESISTANCE. THE PHYSICIAN MANIPULATED THE DEVICE IN AN ATTEMPT TO ADVANCE IT INTO POSITION IN THE VESSEL. THE PHYSICIAN REPORTED A TACTILE SENSATION OF THE DEVICE POPPING IN AND BELIEVED THAT THE DEVICE HAS ADVANCED TO POSITION. HE RETRACTED THE PLUNGER AND PULLED BACK ON THE DEVICE AND NOTED THE SHEATH WAS NOT ATTACHED. A VASCULAR SURGEON WAS CALLED IN TO RECAPTURE THE DEVICE. THE PROCEDURE WAS COMPLETED AND THE PT RECOVERED WITHOUT COMPLICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention