BEUDAMED
    FDA Adverse Event Other Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1530934 · Received October 26, 2009

    Report

    Report Number
    3004742046-2009-00286
    Event Type
    Other
    Date Received
    October 26, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 1, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    2024168-10/2-09-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON OCTOBER 1, 2009, ABBOTT VASCULAR INITIATED A VOLUNTARY RECALL OF A SINGLE LOT OF THE RX ACCULINK CAROTID STENT SYSTEM WITH A PART NUMBER OF 1011344-40 AND A LOT NUMBER OF 9081851. AN FDA ASSIGNED CORRECTION/REMOVAL NUMBER HAS NOT YET BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THE INTERNAL ABBOTT VASCULAR RECALL REPORT (B)(4) AS SUBMITTED TO FDA, (B)(4), UNDER 21 CFR PART 806.10. NOTIFICATION OF VOLUNTARY RECALL. THERE HAVE BEEN NO CUSTOMER REPORTED EVENTS IN THE FIELD. REPORTED NON-CONFORMANCE EVALUATED THROUGH THE VOLUNTARY RECALL PROCESS. THERE HAVE BEEN NO CUSTOMER REPORTED EVENTS. INTERNAL INVESTIGATION PERFORMED AND A POTENTIAL FOR THE DEVICE TO NOT MEET CATHETER SHAFT TENSILE STRENGTH SPECIFICATIONS WAS IDENTIFIED.

    Description of Event or Problem · 1

    ON OCTOBER 1, 2009, ABBOTT VASCULAR INITIATED A VOLUNTARY RECALL OF A SINGLE LOT CONSISTING OF 22 UNITS OF THE RX ACCULINK CAROTID STENT SYSTEM (PART NUMBER 1011344-40, LOT NUMBER 9081851). THE RECALL WAS INITIATED WHEN AN INTERNAL INVESTIGATION DETERMINED THAT THIS LOT MAY NOT MEET OUR QUALITY SPECIFICATIONS FOR CATHETER SHAFT TENSILE STRENGTH. ABBOTT VASCULAR HAS NOT RECEIVED ANY CUSTOMER COMPLAINTS FOR THE LOT NUMBER INVOLVED IN THE RECALL. DEVICE RECOVERY ACTIVITIES DETERMINED THAT TWO DEVICES OF THE AFFECTED LOT WERE USED AND DEPLOYMENT OF BOTH DEVICES WAS REPORTED AS UNEVENTFUL. THIS ACTION DOES NOT AFFECT PTS HAVING SUCCESSFULLY IMPLANTED STENTS AND DOES NOT AFFECT ANY INVENTORY BEYOND THE UNITS IDENTIFIED HERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9081851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA