BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1051049 · Received May 22, 2008

    Report

    Report Number
    2953144-2008-00941
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ABBOTT VASCULAR INC.- 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FAILURE TO DEPLOY, DIFFICULT TO REMOVE, DISTAL GUIDE DETACHED. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE:SURGICAL RETRIEVAL. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE A-T ATTEMPTED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER A PERIPHERAL INTERVENTION PROCEDURE USING AN ANTEGRADE APPROACH. REPORTEDLY, AFTER RETRACTING THE NEEDLE PLUNGER TO RETRIEVE THE SUTURE, THE SUTURE WAS NOT PRESENT. THE LEVER WAS CYCLED TO RETRACT/PARK THE FOOT AND REMOVE THE DEVICE, BUT THE DEVICE COULD NOT BE REMOVED. MANUAL COMPRESSION WAS HELD TO STOP THE BLEEDING, WHEN IT WAS NOTICED THAT THE DISTAL GUIDE HAD "SNAPPED" AND DETACHED IN THE VESSEL. THE DISTAL GUIDE WAS SURGICALLY REMOVED AND THE ARTERY WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. 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 INC.- REDWOOD CITY NA 63011-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention