BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 729013 · Received June 22, 2006

    Report

    Report Number
    3004742046-2006-00290
    Event Type
    Injury
    Date Received
    June 22, 2006
    Date of Event
    March 27, 2006
    Report Date
    March 28, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NFA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RX ACCULINK, PART # 1011344-30, PART # 5122051, REFERENCED IN D11, IS BING FILED UNDER MANUFACTURER REPORT NUMBER 3004742046-2006-00289.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULTY RECOVERING FILTER. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS: NONE REPORTED. IT WAS REPORTED THAT DURING THE LEFT INTERNAL CAROTID ARTERY PROCEDURE, THERE WAS AN INABILITY TO ADVANCE THE FLEX TIP RECOVERY CATHETER. THE FILTER WAS RETRIEVED WITH THE SHAPEABLE TIP RECOVERY CATHETER SUCCESSFULLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NFA GUIDANT ENDOVASCULAR SOLUTIONS NA 6011251

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention STENT: RX ACCULINK.