BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1851666 · Received September 29, 2010

    Report

    Report Number
    2953144-2010-02248
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 25, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT A PHYSICIAN IN-TRAINING IN THE USE OF THE PROSTAR XL DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY USING A PRE-CLOSE TECHNIQUE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE SUTURES, A NON-ABBOTT GUIDE WIRE WAS FED BACK THROUGH THE DEVICE TO MAINTAIN VESSEL ACCESS UNTIL THE DEVICE WAS COMPLETELY REMOVED FROM THE PT. THE NON-ABBOTT GUIDE WIRE BECAME STUCK IN THE PROSTAR XL DEVICE. BECAUSE ENOUGH OF THE GUIDE WIRE REMAINED IN THE VESSEL, THE GUIDE WIRE WAS CUT AT THE J-TIP OF THE PROSTAR XL. A SHEATH WAS INSERTED AND THE GUIDE WIRE WAS EXCHANGED WITH ANOTHER GUIDE WIRE. HEMOSTASIS WAS ACHIEVED USING THE PROSTAR XL. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 880446H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OTHER: HEPARIN| GUIDE WIRE: 0.35MM TERUMO