BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1851202 · Received September 30, 2010

    Report

    Report Number
    2953144-2010-02376
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 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). EVAL OF THE RETURNED DEVICE FOUND THE SHEATH APPEARED NORMAL. THERE WAS NO KINK FOUND ON THE SHEATH. DURING THE INVESTIGATION, THE GUIDEWIRE WAS BACKLOADED AND FRONTLOADED WITHOUT A PROBLEM. THE PROSTAR XL DEVICE IS TO BE USED OVER A STANDARD 0.038 INCH OR SMALLER GUIDE WIRE. BASED ON THE INVESTIGATION FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION; THEREFORE, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. NO MFG OR QUALITY ISSUES WERE DETECTED. 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 TRAINED IN THE USE OF THE PROSTAR XL DEVICE ATTEMPTED TO INSERT A 0.035 J TIP GUIDE WIRE DURING A PRE-CLOSE PROCEDURE. THE PHYSICIAN FELT THE GUIDE WIRE CROSSED THE HEMOSTATIC VALVE BUT BECAME STUCK INSIDE THE PROSTAR XL DEVICE. THE J TIP GUIDE WIRE WAS REMOVED AND A STRAIGHT GUIDE WIRE WITH A MOVABLE CORE WAS SUCCESSFULLY INSERTED INTO THE PROSTAR XL DEVICE. THERE WAS NO REPORTED IMPACT TO THE VESSEL CLOSURE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. 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 88044-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN