BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1414532 · Received July 14, 2009

    Report

    Report Number
    2953144-2009-00851
    Event Type
    Injury
    Date Received
    July 14, 2009
    Date of Event
    May 11, 2009
    Report Date
    June 24, 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

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DEVICE #2 - PROSTAR XL (PART# 12322-01, LOT# 72041-6H), IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: RESISTANCE FELT ADVANCING ONTO THE GUIDE WIRE AND NEEDLES FAILED TO DEPLOY. TIME OF DEVICE MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT A PHYSICIAN NOT TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MODERATELY CALCIFIED COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, RESISTANCE WAS FELT WHILE BACK LOADING THE PROSTAR XL DEVICE ONTO THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AND PROSTAR XL WAS ADVANCED INTO POSITION BUT DEPLOYMENT OF THE NEEDLES WAS UNSUCCESSFUL. A GUIDE WAS INSERTED AND THE PROSTAR XL WAS REMOVED AND A SECOND PROSTAR XL WAS USED WITH THE SAME RESULTS. THE SECOND PROSTAR XL WAS REMOVED AND HEMOSTASIS WAS ACHIEVED USING A THIRD PROSTAR XL DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 72041-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GUIDE WIRE: TERUMO| (PART#12322-01| VESSEL CLOSURE: DEVICE #2 - PROSTAR XL