BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1730969 · Received June 17, 2010

    Report

    Report Number
    3004742046-2010-00261
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: SHAPING RIBBON SEPARATION. TIME OF DEVICE ISSUE: UNKNOWN. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING PREPARATION OF THE RX ACCUNET, THERE WAS AN UNSPECIFIED ISSUE WITH THE SLEEVE OVER THE FILTER AND THE INNER WIRE WAS PULLED OUT DURING RETRACTION INTO THE CATHETER. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER RX ACCUNET WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DURING RETURN DEVICE ANALYSIS, SEPARATION OF THE SHAPING RIBBON WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9111051

    Patients

    Seq Age Sex Outcome Treatment
    1