BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1842247 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01956
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    October 29, 2007
    Report Date
    November 1, 2007
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE ENTIRE SUTURE WAS RETURNED PARTIALLY EXPOSED AND THE LINK WAS NORMAL. THE POSTERIOR CUFF WAS OUT OF ITS POCKET, TABS WERE UNTOUCHED AND THE POSTERIOR NEEDLE WAS UNDISTURBED INDICATING A POSTERIOR CUFF MISS OCCURRED. NO NEEDLE STRIKE MARKS WERE OBSERVED. PLUNGER REINSERTION WAS SUCCESSFUL AND FOOT DEPLOYMENT/PARKING AND NEEDLE TRAJECTORY WERE FOUND TO BE ACCEPTABLE. NO MANUFACTURING ISSUES WERE DETECTED. THE ROOT CAUSE OF THE CUFF MISS COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE WITH A PROGLIDE DEVICE THE FOOT WAS ROUTINELY DEPLOYED. AFTER PULLING THE PLUNGER/NEEDLES OUT, THE SUTURE WAS NOT CONNECTED TO THE NEEDLES. A POSSIBLE CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO PATIENT ADVERSE EFFECTS. 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 51038-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention