BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRVINE BIOMEDICAL INC

    MDR report key: 354722 · Received October 4, 2001

    Report

    Report Number
    354722
    Event Type
    Malfunction
    Date Received
    October 4, 2001
    Date of Event
    July 20, 2001
    Report Date
    July 27, 2001
    Manufacturer
    IRVINE BIOMEDICAL INC
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    QUADRAPOLAR ELECTROPHYSIOLOGY CATHETER WHILE IN THE RIGHT ATRIUM, BECAME SNAGGED WHILE DR WAS POSITIONING. WHEN IT WAS FREE AND REMOVED AND ON FLUORO NOTED CATHETER TIP SEPARATED FROM COATING AND PULLED APART. NO CONSEQUENCES. THE LACK OF ADHESIVE IS THE CAUSE OF THE EVENT. NEVERTHELESS, THE ANCHOR WIRES, ACTING AS A SAFETY FEATURE, PREVENTED THE COMPLETE SEPARATION OF THE TIP ELECTRODE. ALL PAPERWORK INTENDED TO DESCRIBE THE MFR OF CATHETERS IS COMPLETE. THIS IS AN ISOLATED CASE OF "MANUFACTURING OPERATOR ERROR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44680 IRVINE BIOMEDICAL INC CATHETER-QUADRAPOLAR DRF IRVINE BIOMEDICAL INC 81956 11-16271

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR