BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1851225 · Received September 30, 2010

    Report

    Report Number
    2953144-2010-02350
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 1, 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 DEVICE WAS RETURNED WITH A NORMAL APPEARING SHEATH. DURING TESTING, A GUIDE WIRE WAS BACK LOADED AND FRONT LOADED WITHOUT A PROBLEM. BASED ON THE FINDINGS, THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. A ROOT CAUSE FOR THE REPORTED EXPERIENCE COULD NOT BE DETERMINED. NO MANUFACTURING OR QUALITY ISSUES WERE DETECTED. A 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 ACHIEVED ARTERIOTOMY CLOSURE OF AN UNSPECIFIED VESSEL AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ALTHOUGH, RESISTANCE WAS FELT AS THE DEVICE WAS BACK LOADED ONTO THE GUIDE WIRE; THE DEVICE WAS SUCCESSFULLY BACK LOADED AND WAS PLACED IN THE VESSEL. HEMOSTASIS WAS ACHIEVED WITH THE PROSTAR XL SUTURE. 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-VASCULAR SOLUTIONS NA 088010-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention