BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1220405 · Received November 4, 2008

    Report

    Report Number
    2953144-2008-01769
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    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
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DEVICES #2- PERCLOSE AT (LOT#49058-6H) IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: SUTURE RETRIEVAL (DEVICE #1). TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE AT DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS PULLED OUT, ONLY THE WHITE SUTURE WAS CAPTURED BY THE NEEDLE PLUNGER. THE DEVICE WAS REMOVED AND A SECOND PERCLOSE AT DEVICE WAS USED; HOWEVER, AFTER HARVESTING THE SUTURE, THE KNOT WAS STUCK AND NOT ABLE TO BE ADVANCED. THE DEVICE WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING MANUAL COMPRESSION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR REDWOOD CITY NA 49058-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention (LOT #49058-6H)| HEPARIN| VESSEL CLOSURE: DEVICE #2- PROGLIDE