BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 2001829 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01216
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (DATE OF EVENT): THE FACILITY REPORTER INDICATED THE EVENT OCCURRED 1.5 WEEKS PRIOR TO THE DATE IT WAS REPORTED TO THE MANUFACTURER REPRESENTATIVE. THE DATE OF (B)(6) 2011 IS BEING USED AS BEST ESTIMATE DATE. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE TWO OTHER PROSTAR DEVICES ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN, TRAINED IN THE USE OF THE PROSTAR XL DEVICE, ATTEMPTED ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY AFTER AN AORTIC PROCEDURE. REPORTEDLY, WHEN THE NEEDLES WERE TAKEN OUT AND THE KNOT WAS DONE, THE PROSTAR SUTURES CAUGHT SUBCUTANEOUS TISSUE. THE DEVICE WAS REMOVED AND A SECOND AND THIRD PROSTAR XL DEVICES WERE ATTEMPTED, BUT WITH THE SAME RESULTS. HEMOSTASIS WAS ACHIEVED USING A FOURTH PROSTAR WITHOUT FURTHER ISSUES. THE PHYSICIAN CLARIFIED THAT THE VESSEL WAS NOT PROPERLY PREPPED PRIOR TO INTRODUCE THE INITIAL THREE PROSTAR DEVICES, AND THAT IS WHY THE PROSTARS FAILED. THEN THE SUBCUTANEOUS TISSUE WAS PROPERLY CUT AND THE FOURTH PROSTAR WAS SUCCESSFUL. THERE WERE NO ADVERSE PATIENT 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 SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention