BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1051047 · Received May 22, 2008

    Report

    Report Number
    2953144-2008-00935
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 30, 2008
    Report Date
    April 30, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. DEVICE #1 - PROGLIDE (PART#12673-04, LOT#60050-6H), REFERENCED IS BEING FILED UNDER MEDWATCH REPORT 2953144-2008-00934.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: KNOT UNRAVELED (DEVICE #2). TIME OF DEVICE MALFUNCTION: DURING PRE-CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED PRE-CLOSURE OF AN UNSPECIFIED ARTERY BEFORE AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AS THE PHYSICIAN WAS DEPLOYING THE PROGLIDE DEVICE, THE KNOT UNRAVELED AND A SECOND PROGLIDE WAS ATTEMPTED WITH THE SAME RESULTS. THE PHYSICIAN WAS USING TWO PROGLIDE DEVICES IN ONE PUNCTURE SITE TO CLOSE A 14FR HOLE. HEMOSTASIS WAS ACHIEVED BY AN UNK METHOD. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 60050-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PART#12673-04| VESSEL CLOSURE: DEVICE #1 - PROGLIDE