BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD TORQUE LINE CATHETER W/4 LUMENS

    MDR report key: 3443498 · Received September 19, 2013

    Report

    Report Number
    2025816-2013-00112
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    January 1, 2013
    Report Date
    July 26, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION: AS PART OF THE MFR'S CONTINUOUS IMPROVEMENT INITIATIVES, A MULTI-DISCIPLINE TEAM WAS INITIATED TO PERFORM IN-DEPTH ANALYSIS OF INTERMITTENT FIELD REPORTS OR CATHETER BALLOON INFLATION ISSUES. FUNCTIONAL DATA OBTAINED FROM PRODUCTION LOTS AND ENGINEERING STUDIES WERE REVIEWED. NO TRENDS/FAILURES IN PERFORMANCE WERE FOUND. A REVIEW AND ANALYSIS OF RAW MATERIAL DATA WAS CONDUCTED. THE ANALYSIS NOTED THAT NEW LOTS OF THE BALLOON MATERIAL (POLYISOPRENE) ARE REC'D EVERY 6 MONTHS, BUT CONSUMPTION CAN VARY BASED ON ORDER DEMANDS. POTENTIAL ROOT CAUSE: POLYISOPRENE IS CONTINUALLY AGAIN, AND BALLOONS MANUFACTURED WITH OLDER MATERIA WHEN SUBJECTED TO CERTAIN CONDITIONS (SHIPPING, HEAT, ETC.) MAY EXPERIENCE MATERIAL DEGRADATION/DETERIORATION. A DETAILED ENGINEERING STUDY DESIGNED TO TEST ADD'L ATTRIBUTES OF THE RAW MATERIALS AGING PROPERTIES IS IN PROGRESS. BALLOONS WERE MANUFACTURED AND ARE BEING TESTED PRE-STERILE, POST-STERILE, POST-STERILE, POST-THERMAL CYCLED AND POST AGED (60C FOR 13 DAYS). AS AN INTERIM MEASURE, THE RAW MATERIAL SHELF LIFE HAS BEEN CHANGED (FROM 3 YEARS FROM DATE OF MANUFACTURER TO 1 YR FROM DATE OF MANUFACTURE) TO ADDRESS ANY POTENTIAL CONTRIBUTING MATERIAL AGING FACTORS. LOT BUILD REVIEW: A REVIEW OF THE MFR LOT BUILD DATABASE OF THE REPORTED LOT# 21-105-Y1 (MFR 11/19/2013) SHOWS ITS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFR BUILD CYCLE. FINDINGS: THE INVOLVED 41239-06 CATHETER DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AND INVESTIGATION. THE EXACT CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING INFLATION FAILURES WITH TWO (2) 41239-06 7F TD TORQUE LINE CATHETERS. IT WAS REPORTED THAT THE CATHETER BALLOONS FAILED TO REMAIN INFLATED WHILE IN PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE CATHETER DEVICE WAS PRE-TESTED DURING SET-UP WITH NO ISSUES DETECTED AT THAT TIME. ALTHOUGH REQUESTED, ADD'L RELEVANT INFO INCLUDING DEVICE USAGE, AND DEVICE RETURN STATUS HAS NOT BEEN PROVIDED TO THE MANUFACTURER. DEVICE RETURN STATUS: THE INVOLVED 41239-06 CATHETER WAS NOT RETURNED FOR ANALYSIS AND CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473525 TD TORQUE LINE CATHETER W/4 LUMENS TD CATHETER DYG ICU MEDICAL, INC. 41239-06 21-105-Y1

    Patients

    Seq Age Sex Outcome Treatment
    1 NI