BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE CLOSER AK

    MDR report key: 435648 · Received December 27, 2002

    Report

    Report Number
    2953144-2002-00203
    Event Type
    Injury
    Date Received
    December 27, 2002
    Date of Event
    December 3, 2002
    Report Date
    December 3, 2002
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE WITH THE PERCLOSE A-T (THE CLOSER AK) DEVICE AFTER AN INTERVENTIONAL PROCEDURE. IT WAS REPORTED THAT TWO DEVICES WERE ATTEMPTED AND BOTH DEVICES HAD EXPERIENCED LINK BREAKS. HEMOSTASIS AND CLOSURE WERE ACHIEVED VIA A FEMOSTOP DEVICE. THE PT WAS THEN TRANSFERRED TO THE FLOOR. AFTER A HALF-HOUR, IT WAS REPORTED THAT THE PT'S RIGHT LEG DISTAL PULSES WERE ABSENT AND THE FOOT WAS COLD. A SURGICAL CONSULT WAS OBTAINED AND THE PT WAS TAKEN TO SURGERY FOR A RIGHT FEMORAL ARTERY PATCH. THE SURGEON REPORTED THAT THE RIGHT FEMORAL ARTERY WAS PARTIALLY OCCLUDED DUE TO A PIECE OF PLAQUE THAT WAS LIFTED UP ABOVE THE PUNCTURE SITE. IT WAS REPORTED THAT THE PT WAS DISCHARGED HOME IN 12/20020. THERE IS NO REPORT OF FURTHER ADVERSE PT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R HEPARIN.