BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1574796 · Received January 8, 2010

    Report

    Report Number
    2953144-2010-00014
    Event Type
    Injury
    Date Received
    January 8, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 21, 2009
    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

    DEVICE #1: PART# 12322-02, LOT# 78027-6H INDICATED IS BEING FILED UNDER MEDWATCH MFR NUMBER 2953144-2010-00013. DEVICE #3: PART #12322-02, LOT #78027-6H INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE #2 NEEDLE MISS. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, DURING PRE-CLOSE NEEDLE DEPLOYMENT, THE NEEDLE TIPS DEFLECTED CAUSING THEM TO MISS THE BARREL STOPPING DEPLOYMENT. A SECOND AND THIRD DEVICE WERE USED WITH THE SAME RESULTS. THE ARTERY WAS SURGICALLY SUTURED CLOSED FOR HEMOSTASIS. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR -REDWOOD CITY NA 78027-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DEVICE #1 AND 3: PROSTAR XL| PART# 12322-02, LOT# 78027-6H