BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1153111 · Received September 8, 2008

    Report

    Report Number
    2953144-2008-01459
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ABBOTT VASCULAR-REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    SYMPTOMS/AE: RETROPERITONEAL BLEED. TIME OF DEVICE MALFUNCTION: AFTER VESSEL CLOSURE. DEVICE MALFUNCTION: NONE. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PERCLOSE A-T DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WITHIN A HALF AN HOUR AFTER CLOSURE, THE NURSING STAFF IDENTIFIED FROM A COMPUTED TOMOGRAPHY SCAN THAT THE PT DEVELOPED A RETROPERITONEAL BLEED ON THE LEFT SIDE. THE PT WAS TAKEN FOR SURGERY TO RESOLVE THE BLEED. THE PT WAS REPORTED TO BE "OKAY NOW." THERE WAS NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    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 64154-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention