BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1772372 · Received July 23, 2010

    Report

    Report Number
    2953144-2010-01458
    Event Type
    Injury
    Date Received
    July 23, 2010
    Report Date
    July 4, 2010
    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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - PATIENT SELECTION, INCORRECT REMOVAL. 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 ISSUE: FAILURE TO DEPLOY NEEDLES. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: SURGICAL HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY OF THE FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, TWO ENDOPROSTHESIS OF ABDOMINAL AORTA PROCEDURES WERE PERFORMED. TWO PROSTAR DEVICES WERE USED TO CLOSE TWO ACCESS SITES (LEFT, RIGHT), IN AN OBESE PT. THE FIRST PROSTAR DEVICE SUCCESSFULLY ACHIEVED HEMOSTASIS, SITE NOT REPORTED. THE SECOND PROSTAR USED IN THE ENDOPROSTHESIS OF A VESSEL WITH A LARGER DIAMETER COMPARED WITH THE FIRST SITE. DURING DEPLOYMENT OF THE NEEDLES, ONLY THREE NEEDLES WERE VISIBLE. ONE NEEDLE REMAINED IN THE SKIN. THE DEVICE WAS "BROKEN" TO RETRIEVE THE NEEDLE FROM THE SKIN. HEMOSTASIS WAS SURGICALLY ACHIEVED. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROSTAR