BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1833207 · Received September 9, 2010

    Report

    Report Number
    2953144-2010-01890
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ABBOTT VASCULAR - 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN REC'D. PERCLOSE PROGLIDE DEVICE NUMBERS 1, 2, 3, 4, 5, 6 AND 7, PART# 12673-03, LOT# UNK, INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE #8 ISSUE: NEEDLE-TO-CUFF MISS. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE, ATTEMPTED BILATERAL ARTERIOTOMY CLOSURE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, USING A "PERCLOSE" TECHNIQUE OF HEAVILY CALCIFIED AND FIBROUS LEFT COMMON FEMORAL ARTERY A NEEDLE-TO-CUFF MISS OCCURRED. WHEN THE NEEDLE PLUNGER WAS REMOVED, NO SUTURE WAS PRESENT ON THE NEEDLES. THE DEVICE WAS REMOVED AND A SECOND, THIRD, AND FOURTH PROGLIDE DEVICE WERE ATTEMPTED BUT ALSO RESULTED IN A NEEDLE-TO-CUFF MISS. A FIFTH PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 - REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 1, 2, 3, 4, 5, 6, & 7, PART# 12673-03, LOT# UNK.| PERCLOSE PROGLIDE DEVICE NUMBERS