BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1842253 · Received September 18, 2010

    Report

    Report Number
    2953144-2010-01950
    Event Type
    Injury
    Date Received
    September 18, 2010
    Date of Event
    April 15, 2009
    Report Date
    April 21, 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
    AS
    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. THE FIRST PROSTAR, INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN NOT TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE ARTERIAL PUNCTURE WAS TOO LARGE TO ENABLE ENOUGH TISSUE CAPTURE FOR ARTERIOTOMY CLOSURE. THE DEVICE WAS REMOVED AND A SECOND PROSTAR XL WAS USED BUT WITH THE SAME RESULT. HEMOSTASIS WAS ACHIEVED WITH SURGICAL SUTURES. THE ARTERIAL PUNCTURE WAS REPORTED TO BE 20FR THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROSTAR (PART 12322-02, LOT UNK)