BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1842374 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01985
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    October 31, 2008
    Report Date
    May 27, 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

    (B)(4). 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

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER THE PROCEDURE, THE PT EXPERIENCED PAIN IN THE RIGHT GROIN AND WAS GIVEN 100MG OF FENTANYL. THE PT HAD PAIN AGAIN SEVEN (7) HOURS AFTER THE PROCEDURE. APPROXIMATELY ONE (1) HOUR FOLLOWING THE PROCEDURE, THE PT EXPERIENCED GROIN DRAINAGE. MANUAL PRESSURE WAS APPLIED FOR FIVE (5) MINUTES FOLLOWED BY A CHITOSEAL TOPICAL HEMOSTASIS PAD AND A 10LB SANDBAG. THERE WERE NO ADVERSE PT SEQUELA REPORTED. THOUGH REQUESTED, 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention