BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1414472 · Received July 10, 2009

    Report

    Report Number
    2953144-2009-00837
    Event Type
    Injury
    Date Received
    July 10, 2009
    Date of Event
    November 13, 2008
    Report Date
    June 15, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: HEMATOMA, TISSUE TRACT OZZE, ACCUSE SITE PAIN. TIME OF SYMPTOMS/AE: AFTER VESSEL CLOSURE. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PERCLOSE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, APPROXIMATELY 30 MINUTES AFTER ARTERIOTOMY CLOSURE, THE GROIN DRESSING WAS NOTED TO HAVE A SCANT AMOUNT OF BLOODY DRAINAGE/OOZE. APPROXIMATELY 25 MINUTES LATER A 4 CM HEMATOMA/ECCHYMOSIS WAS NOTED. NINE MINUTES OF MANUAL COMPRESSION WAS APPLIED FOLLOWED BY PLACEMENT OF A FEMOSTOP. APPROXIMATELY 10 MINUTES LATER THE DRESSING WAS NOTED TO BE SATURATED AND WAS CHANGED. APPROXIMATELY 4 HOURS LATER THE DRESSING WAS NOTED TO BE DRY AND INTACT. THE NEXT MORNING THE PT REPORTED "ACHING, DULL" RIGHT FEMORAL SITE PAIN, WHICH WAS TREATED WITH UNSPECIFIED MEDICATIONS AND RESOLVED APPROXIMATELY ONE HOUR LATER. THE PT WAS REASSESSED AND DENIED EXPERIENCING FURTHER PAIN. THE PT WAS REPORTED TO HAVE BEEN PRESCRIBED ASPIRIN AND CLOPIDOGREL, WHICH MAY HAVE INFLUENCED THE TISSUE TRACT BLEEDING/OOZE. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention CLOPIDOGREL| OTHER: ASPIRIN