BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1884471 · Received October 19, 2010

    Report

    Report Number
    2953144-2010-02527
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE THREE PERCLOSE PROGLIDE WITH THE SAME PART AND LOT NUMBERS (PART 12673-03, LOT 910326H) INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. (B)(4) PATIENT SELECTION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, UNSPECIFIED IF TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A SLIGHTLY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND THREE ADDITIONAL PROGLIDES WERE USED WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED WITH ANOTHER PERCLOSE PROGLIDE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION 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 - VASCULAR SOLUTIONS NA 910326H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THREE PERCLOSE PROGLIDE (PART 12673-03,| LOT 91032-6H)