BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1895202 · Received November 8, 2010

    Report

    Report Number
    2953144-2010-02761
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    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 CUSTOMER REPORTED, THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED, THEREFORE, LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    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 THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, IT WAS VERY DIFFICULT TO ADVANCE THE GUIDE WIRE (NON-ABBOTT GUIDE WIRE) THROUGH THE PROSTAR XL TO REMOVE IT: THE GUIDE WIRE STOPPED AT THE AREA OF THE HEMOSTASIS VALVE LOCATED IN THE DEVICE JUST DISTAL TO THE GUIDE WIRE EXIST PORT. THE PHYSICIAN RETRACTED THE WIRE, ADVANCED THE STIFFER END (BACKSIDE) OF A .035 INCH WIRE INTO THE GUIDE WIRE EXIT PORT TO WIDEN THE NARROW AREA AT THE HEMOSTASIS VALVE, REMOVED THE GUIDE WIRE AND INSERTED IT AGAIN WITH THE WEAK TIP. WITH MORE EFFORT AND SLIGHT PUSHING, IT WAS POSSIBLE TO ADVANCE THE WIRE AND THE PROSTAR XL COULD BE USED TO CLOSE THE PUNCTURE SITE. HEMOSTASIS WAS ACHIEVED WITH THIS DEVICE. THERE WAS NO ADVERSE PT EFFECT. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRES: 0.035" UNSPECIFIED NON-ABBOTT| GUIDE WIRE.