BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 1881095 · Received October 1, 2010

    Report

    Report Number
    2030404-2010-00165
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    IRVINE BIOMEDICAL, A ST. JUDE MED COMPANY
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER IS CAUSED BY THE LUMEN BREAKING AT THE EDGE OF THE CATHETER HANDLE IN THE PROTECTING TUBE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THIS ISSUE. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 10/01/2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SALINE WAS LEAKING AT THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY ABLATION CATHETER CARDIAC PERCUTANEOUS ABLATION CATHETER OAD IRVINE BIOMEDICAL, A ST. JUDE MED COMPANY 83565 K27321

    Patients

    Seq Age Sex Outcome Treatment
    1