BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CLOSER AK

    MDR report key: 641741 · Received August 25, 2005

    Report

    Report Number
    2953144-2005-00089
    Event Type
    Malfunction
    Date Received
    August 25, 2005
    Date of Event
    July 27, 2005
    Report Date
    July 27, 2005
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED DUE DEVICE STUCK IN GROIN AND FOOT BREAK. THE PHYSICIAN WAS PERFORMING CLOSURE OF AN ARTERIOTOMY SITE WITH THE PERCLOSE A-T (CLOSER AK) DEVICE FOLLOWING AN INTERVENTIONAL PROCEDURE. REPORTEDLY, FLUOROSCOPY WAS NOT PERFORMED PRIOR TO THE CLOSURE; THEREFORE, THE VESSEL SIZE, CONDITION AND SITE CONFIRMATION ARE UNK. THE PT DID NOT HAVE SCAR TISSUE AT THE GROIN SITE. AFTER DEPLOYING THE FOOT, THE PHYSICIAN FULLY DEPRESSED THE PLUNGER BUT FELT THAT "SOMETHING IS WRONG". HE ATTEMPTED TO PARK THE FOOT IN ORDER TO REMOVE THE DEVICE BUT "COULDN'T PARK THE LEVER COMPLETE." THE DEVICE BECAME STUCK IN THE GROING AND FLUOROSCOPY WAS PERFORMED IN ORDER TO DETERMINE THE CAUSE OF THE DEVICE BEING STUCK. FLUOROSCOPY REVEALED A "DEPLOYED FOOT." AFTER "SOME MANIPULATION" THE PHYSICIAN WAS ABLE TO REMOVE THE STUCK DEVICE. REPORTEDLY, "ONE HALF OF THE FOOT (WAS) LEFT IN THE VESSEL, THE OTHER COULD BE REMOVED." HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION AND THERE WERE NO ADVERSE PT REACTIONS. THE PT WAS INFORMED OF THE ISSUE AND WAS INSTRUCTED TO IMMEDIATELY CONTACT THE HOSPITAL IF THERE WERE ANY PROBLEMS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE CLOSER AK SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA 290896H

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other