BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1047254 · Received May 16, 2008

    Report

    Report Number
    2953144-2008-00903
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PERCLOSE AT (BOTH - PART #12337-05; LOT #60044-6H), ARE BEING FILED UNDER MEDWATCH REPORTS (DEVICE #1) 2953144-2008-00902 AND (DEVICE #3) UNDER A SEPARATE MEDWATCH REPORT. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED; HOWEVER, UNUSED REP SAMPLES ARE BEING RETURNED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: KNOT LOCK (DEVICE #2). TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE AT ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PHYSICIAN COULD NOT ADVANCE THE KNOT TO THE ARTERIAL SURFACE. THE KNOT APPEARED NOT TO BE CORRECTLY PRE-FORMED. A GUIDE WIRE WAS RE-INSERTED INTO THE ARTERY AND THE DEVICE WAS REMOVED. TWO PERCLOSE AT DEVICES WERE ATTEMPTED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A PERCLOSE PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 60044-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VESSEL CLOSURE: DEVICE #1 AND DEVICE #3 - PERCLOSE| AT (BOTH - PART# 12337-05, LOT #60044-6H)