BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEM

    MDR report key: 826341 · Received February 2, 2007

    Report

    Report Number
    2953144-2007-00056
    Event Type
    Other
    Date Received
    February 2, 2007
    Date of Event
    January 4, 2007
    Report Date
    January 4, 2007
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT IS FORTHCOMING. ANY RELEVANT FINDING WILL BE SUBMITTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING THE PERCLOSE AT. AFTER REMOVING THE PERCLOSE AT, THE PHYSICIAN OBSERVED A SMALL PLASTIC TUBE IN THE ACCESS SITE. IT IS UNKNOWN HOW THE PIECE OF TUBE WAS REMOVED FROM THE PATIENT. HEMOSTATIS WAS ACHIEVED WITH MANUAL COMPRESSION. REPORTEDLY, THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEM SUTURE MEDIATED CLOSURE SYSTEM MGB ABBOTT VASCULAR INC. NA 43073-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other