BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 1790299 · Received August 6, 2010

    Report

    Report Number
    2030404-2010-00094
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    May 28, 2010
    Report Date
    August 6, 2010
    Manufacturer
    IRVINE BIOMEDICAL, INC., A ST. JUDE MEDICAL CO.
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL COMPLAINT DID NOT CLEARLY INDICATE A REPORTABLE EVENT. HOWEVER, INVESTIGATION ON JULY 8 CONFIRMED A HANDLE LEAK WHICH IS REPORTABLE. THE RETURNED UNIT WAS VISUALLY AND FUNCTIONALLY EXAMINED. A LEAK WAS CONFIRMED FROM INSIDE THE HANDLE DUE TO A DAMAGED LUMEN. CATHETERS ARE 100% INSPECTED IN-PROCESS AND AT FINAL INSPECTION FOR ELECTRICAL AND MECHANICAL INTEGRITY TO ENSURE THEY MET THE SPEC REQUIREMENTS.

    Description of Event or Problem · 1

    AFTER TWO HOURS OF AF ABLATION, THE IRRIGATION PORT WAS BROKEN AND THE SALINE SOLUTION DID NOT IRRIGATE THROUGH THE CATHETER, BECAUSE IT DID NOT PASS THROUGH THE CATHETER LUMEN, INSTEAD IT LEAKED OUT OF THE HANDLE BEFORE PASSING INSIDE THE MAIN BODY OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY ABLATION CATHETER CARDIAC PERCUTANEOUS ABLATION CATHETER OAD IRVINE BIOMEDICAL, INC., A ST. JUDE MEDICAL CO. 83565 K23327

    Patients

    Seq Age Sex Outcome Treatment
    1