BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3893858 · Received June 12, 2014

    Report

    Report Number
    3008493244-2014-00017
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ARSTASIS, INC.
    Product Code
    DYB
    PMA / PMN Number
    K140201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT FAILURE ANALYSIS WAS NOT POSSIBLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS LOT AND NO NONCONFORMING MATERIAL REPORTS HAVE BEEN INITIATED THAT ARE RELATED TO THIS FAILURE MODE. SEE SCANNED PAGE. BASED ON THE REVIEW COMPLETED, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS OUT OF SPECIFICATION. THE ROOT CAUSE, BASED ON AVAILABLE INFORMATION, IS UNKNOWN AS IT CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    THIS WAS AN INTERVENTIONAL PERIPHERAL CASE WITH ACCESS ON THE LEFT SIDE. THE LEFT FEMORAL WAS WIDELY PATENT WITH NO TORTUOSITY, CALCIFICATION, OR SCARRING NOTED. THE INITIAL ACCESS PUNCTURE WAS SATISFACTORY. THE PROCEDURE PROCEEDED AS PLANNED UNTIL A SMALL HEMATOMA STARTED FORMING PRIOR TO SHEATH PULL AND PRESSED OUT. WHEN THE SHEATH WAS PULLED, A HEMATOMA (6X2 CM) FORMED, WHICH WAS TREATED WITH MANUAL COMPRESSION. THE PATIENT WAS DISCHARGED THE SAME DAY AFTER SEVERAL HOURS OF BED REST POST PROCEDURE WITH INSTRUCTIONS TO CONTACT THE PHYSICIAN IF THE HEMATOMA EXPANDED. THE FOLLOWING MORNING, (B)(6) 2014, THE PATIENT REPORTED THAT THE HEMATOMA EXPANDED AND WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM. ULTRASOUND ASSESSMENT WAS NORMAL. TREATMENT ORDERED WAS TO ALTERNATE ICE / HEAT AND PAIN MEDICATION. THE PATIENT WAS DISCHARGED THE SAME DAY WITH INSTRUCTIONS TO RETURN TO THE EMERGENCY ROOM IF WORSE. THE PATIENT RECOVERED WITHOUT FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348897 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS, INC. 14C18045

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization 5F IM CATHETER| 6F SHEATH| POWERCROSS BALLOON| SPORT WIRE| ARMADA BALLOON| TERUMO GLIDEWIRE| 5F SHEATH| VISAPAQUE