BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1071308 · Received July 8, 2008

    Report

    Report Number
    3004742046-2008-00168
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    May 31, 2007
    Report Date
    June 20, 2008
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE RX ACCUNET RC2 DEVICE WAS NOT RETURNED; THEREFORE, IT IS UNK WHY IT WAS UNABLE TO ADVANCE. THE FINISHED DEVICE LOT HISTORY RECORD REVIEW DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINANT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNABLE TO RETRIEVE EPD WITH RC2. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, DURING ATTEMPTED RETRIEVAL OF THE RX ACCUNET FILTER, THE RX ACCUNET RC2 LOW PROFILE RECOVERY CATHETER CAUGHT ON THE STENT STRUTS AND COULD NOT ADVANCE THROUGH THE STENT. THE PHYSICIAN SWITCHED TO THE SHAPEABLE TIP DESIGN RC1, AND WAS ABLE TO CAPTURE THE FILTER SUCCESSFULLY. THERE WERE NO REPORTED PT SEQUELAE. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NTE NA 7031651

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RX ACCULINK| HEPARIN