BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1420456 · Received May 22, 2009

    Report

    Report Number
    2953144-2009-00614
    Event Type
    Other
    Date Received
    May 22, 2009
    Date of Event
    May 6, 2009
    Report Date
    May 6, 2009
    Manufacturer
    ABBOTT VASCULAR - REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    2024168-5/13/09-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT VASCULAR INITIATED A RECALL OF A SINGLE LOT OF STARCLOSE VASCULAR CLOSURE SYSTEMS. THE TWO USED DEVICES WERE DISCARDED BY THE USER FACILITY AFTER COMPLETION OF THE PROCEDURE, AS THE DEVICES PERFORMED AS EXPECTED. WITHOUT RETURN OF THE USED DEVICES, IT CANNOT BE DETERMINED IF THE COMPONENTS IN THE USED DEVICES WERE IMPACTED. AN FDA ASSIGNED CORRECTION/REMOVAL NUMBER HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ON MAY 6, 2009, ABBOTT VASCULAR INITIATED A RECALL OF A SINGLE LOT OF STARCLOSE VASCULAR CLOSURE SYSTEMS. THE RECALL WAS INITIATED WHEN AN INTERNAL INVESTIGATION DETERMINED THAT THERE IS A LOW PROBABILITY THAT UNITS FROM THE LOT MAY NOT MEET OUR QUALITY STANDARDS FOR STERILITY, DUE TO A CONTAMINANT ON A VENDOR SUPPLIED COMPONENT. ALL UNITS WERE ETO STERILIZED IN ACCORDANCE WITH DEVICE SPECIFICATIONS. ABBOTT VASCULAR HAS NOT RECEIVED ANY CUSTOMER COMPLAINTS FOR THE LOT NUMBER INVOLVED IN THE RECALL. SUBMISSION OF THIS MEDWATCH REPORT IS A RESULT OF DEVICE RECOVERY ACTIVITIES WHERE IT WAS DETERMINED THAT TWO DEVICES FROM THE AFFECTED LOT WERE USED FOR BILATERAL ARTERIOTOMY CLOSURE IN ONE PT. DEPLOYMENT OF BOTH DEVICES WAS UNEVENTFUL WITH HEMOSTASIS ACHIEVED. THE PHYSICIAN INDICATED THAT THE PT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS TO DATE. HE INFORMED ABBOTT VASCULAR THAT HIS STANDARD PROTOCOL IS TO ROUTINELY ADMINISTER PROPHYLACTIC ANTIBIOTICS TO ALL HIS PTS UNDERGOING PERCUTANEOUS CATHETERIZATION PROCEDURES. NO OTHER DEVICES FROM THIS LOT WERE USED CLINICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR - REDWOOD CITY NA 75040-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA