BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 1865307 · Received September 29, 2010

    Report

    Report Number
    2030404-2010-00148
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    July 14, 2010
    Report Date
    September 8, 2010
    Manufacturer
    IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT RECEIVED ON (B)(6) 2010, OF "TEMPERATURE SENSOR NOT FUNCTIONING" DID NOT MEET MDR REPORTING CRITERIA. INVESTIGATION 09/08/2010 OF THE RETURNED DEVICE REVEALED A HANDLE LEAK WHICH DOES MEET MDR REPORTING CRITERIA. INVESTIGATION OF THE RETURNED DEVICE CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER 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: 09/29/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(6) 2010. DATE INVESTIGATION COMPLETED: 09/08/2010.

    Description of Event or Problem · 1

    INVESTIGATION OF A RETURNED CATHETER REVEALED A HANDLE LEAK.

    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 MEDICAL COMPANY 83353 K26594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK