BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1496810 · Received August 25, 2009

    Report

    Report Number
    3004742046-2009-00212
    Event Type
    Malfunction
    Date Received
    August 25, 2009
    Date of Event
    August 6, 2009
    Report Date
    August 6, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED; HOWEVER, THE INVESTIGATION IS NOT YET COMPLETED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MISLABELED. TIME OF MALFUNCTION: DURING DEVICE TESTING. SYMPTOMS/AE: NO PT INVOLVEMENT. IT WAS REPORTED THAT DURING MODEL TESTING, AN RX ACCULINK 7-10/40 AND RX ACCULINK 10X40 WERE PREPPED AND PLACED ON THE TABLE. AT THAT TIME IT WAS NOTICED THAT THE LABELING ON BOTH DEVICE HANDLES WAS IDENTIFIED AS 10X40, LOT NUMBER 9021951. THE PACKAGE LABELING FOR THE RX ACCULINK 7-10/40 INDICATED PART/LOT 1011344-40/8091651; HOWEVER, WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGING AND INSPECTED ON THE TABLE, THE HANDLE IDENTIFICATION WAS 10/40, LOT 9021951. SIZE AND LOT NUMBER DID NOT CORRESPOND WITH THE PACKAGE LABELING. THE PACKAGE LABELING AND DEVICE IDENTIFICATION OF THE SECOND RX ACCULINK (1011342-40/9021951) CORRESPONDED WITH THE IDENTIFICATION ON THE DEVICE HANDLE. NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8091651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA