BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1884485 · Received October 19, 2010

    Report

    Report Number
    2953144-2010-02531
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE DEVICE, UNSUCCESSFULLY PERFORMED PRE-CLOSURE PLACEMENT OF THE PERCLOSE PROGLIDE SUTURES IN THE COMMON FEMORAL ARTERY PRIOR TO AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE SUTURE AND PARKING THE FOOT, DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE FROM THE TISSUE TRACT. THE TISSUE TRACT WAS ENLARGED FREEING THE DEVICE FOR REMOVAL. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE SUTURE WAS ENTANGLED AT THE SUTURE-BEARING OPENING. THE DEVICE WAS REMOVED OVER A GUIDE WIRE AND A SECOND PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO ADDITIONAL 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-VASCULAR SOLUTIONS NA 90030-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention PROCEDURAL SHEATH 8F