BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CLOSER AK

    MDR report key: 533193 · Received July 6, 2004

    Report

    Report Number
    2953144-2004-00087
    Event Type
    Injury
    Date Received
    July 6, 2004
    Date of Event
    June 2, 2004
    Report Date
    June 9, 2004
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTED DUE TO DEVICE BREAK. THE PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE WITH THE PERCLOSE A-T (CLOSER AK) DEVICE AFTER AN INTERVENTIONAL PROCEDURE. HOWEVER, THE PHYSICIAN CHOSE NOT TO PERFORM THE INTERVENTION BECAUSE THE VESSEL WAS SO HIGHLY CALCIFIED AND THE PT'S BLOOD PRESSURE WAS REPORTED TO BE 200/140 MMHG. THE PHYSICIAN CHOSE TO CLOSE THE PT WITH THE PERCLOSE A-T DEVICE. INSERTION OF THE DEVICE WAS DIFFICULT. A "LINK MISS" OCCURRED AND UPON REMOVAL OF THE DEVICE, THE DEVICE WOULD NOT DISLODGE FROM THE PT. IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE DEVICE, THE FOOT WAS OPENED AND CLOSED. THE PHYSICIAN "PULLED SO HARD ON THE DEVICE AND IT BROKE INTO 2 PIECES DIRECT AT THE PART OF THE ROOT." THE SHEATH REMAINED IN THE PT. THE PT WAS TAKEN TO SURGERY IN ORDER TO REMOVE THE SHEATH. IT IS UNKNOWN WHETHER THE INCIDENT EXTENDED THE PT'S HOSPITALIZATION. ALSO, THE PT'S OUTCOME IS UNKNOWN. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE CLOSER AK SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA 140036H

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention