BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1083007 · Received July 28, 2008

    Report

    Report Number
    2953144-2008-01244
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #1: PROGLIDE, PART #12673-05, LOT #64234-6H INDICATED IS BEING FILED UNDER MEDWATCH MFR NUMBER 2953144-2008-01239. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED; REVIEW OF THE DEVICE HISTORY RECORDED IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #2 NONE. TIME OF MALFUNCTION: AFTER VESSEL CLOSURE. SYMPTOMS/AE: OOZING. IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING ATTEMPTED ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY USING THE PROGLIDE DEVICE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, IT WAS NOTICED THAT WHEN RETRACTING THE NEEDLES THERE WERE NO SUTURES PRESENT AT THE END OF THE NEEDLE. A SECOND PROGLIDE WAS USED TO ACHIEVE HEMOSTASIS. AFTER VESSEL CLOSURE, THERE WAS OOZING, WHICH WAS STOPPED AFTER FOUR MINUTES OF MANUAL COMPRESSION. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, 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 REDWOOD CITY NA 64234-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEVICE #1: PROGLIDE| SHEATH: 7 FR CORDIS| GUIDE WIRE: TERUMO| DIL CATH BSX| STENT: EXPRESS