BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1772247 · Received July 22, 2010

    Report

    Report Number
    2953144-2010-01449
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 29, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    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 CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING NEEDLE DEPLOYMENT, ONE NEEDLE DID NOT DEPLOY. THE DEVICE WAS REMOVED, RE-INSERTED, AND DEPLOYED A SECOND TIME, BUT WITH THE SAME RESULTS. THE DEVICE WAS REMOVED AND THE VESSEL WAS SURGICALLY SUTURED TO ACHIEVE HEMOSTASIS. 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 - REDWOOD CITY NA 88036-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention