BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CLOSER S 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1062251 · Received April 8, 2008

    Report

    Report Number
    2953144-2008-00235
    Event Type
    Malfunction
    Date Received
    April 8, 2008
    Date of Event
    January 15, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: CUFF MISS. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE USING A CLOSER S DEVICE AFTER AN INTERVENTIONAL PROCEDURE. THE UNSPECIFIED VESSEL WAS REPORTED TO BE MILDLY CALCIFIED. A CUFF MISS OCCURRED. A PERCLOSE AT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE CLOSER S 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 40054-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE CATH: HEARTRAIL 7F| VESSEL CLOSURE: PERCLOSE AT