BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1671485 · Received April 29, 2010

    Report

    Report Number
    2953144-2010-00734
    Event Type
    Injury
    Date Received
    April 29, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 8, 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
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4) - PATIENT SELECTION. DEVICE #1 AND #2: PART #12322-02, LOT #86044-6H INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE #3 ISSUE: SUTURE BREAK. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A HEAVILY CALCIFIED RIGHT COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, "THE SUTURES WERE COMPLETELY ROLLED UP AND WHEN THEY TRIED TO REMOVE THEM AND THEY ALWAYS BROKE." A SECOND AND THIRD PROSTAR XL DEVICE WERE USED WITH THE SAME RESULTS. A NON-ABBOTT ARTERIOTOMY CLOSURE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED PATIENT ADVERSE EFFECTS. THOUGH REQUESTED, 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 86044-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention LOT #86044-6H| DEVICE #1 AND #2, PROGLIDE PART #12322-02| ANGIOSEAL 8F