BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1131030 · Received August 21, 2008

    Report

    Report Number
    3004742046-2008-00198
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    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 CUSTOMER REPORTED THE DEVICE IS TO BE RETURNED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FAILURE TO RECOVER EMBOLIC PROTECTION DEVICE WITH RC2. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE RECOVERY CATHETER 2 (RC2) WAS UNABLE TO PASS THROUGH THE STENT TO RECOVER THE EMBOLIC PROTECTION DEVICE, POSSIBLY DUE TO THE PT'S ANATOMY. THE DEVICE WAS REMOVED WITHOUT TISSUE. RECOVERY CATHETER 1 (RC1) WAS INSERTED, CROSSED THE STENT, AND SUCCESSFULLY CAPTURED THE EMBOLIC PROTECTION DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. ONE DAY POST PROCEDURE, THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7071651

    Patients

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