BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1080408 · Received July 22, 2008

    Report

    Report Number
    2953144-2008-01224
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 30, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PT AND DEVICE INFO. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. 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: SUTURE BREAK. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY USING THE PROGLIDE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, DURING THE PROCEDURE "THE SUTURES RUPTURED". THE DEVICE WAS REMOVED AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR INC.- REDWOOD CITY NA 64053-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention