BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD TORQUE LINE CATHETER

    MDR report key: 2956596 · Received January 10, 2013

    Report

    Report Number
    2025816-2012-00113
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    October 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFRS INVESTIGATION AND ANALYSIS: DEVICE RETURN: ONE USED 41239-06 TD CATHETER; ONE PACKAGED SAME LOT 41239-06 SAMPLE, ONE PKGD CORDIS AVANTI 8FR INTRODUCER/SHEATH WERE RETURNED. VISUAL INSPECTION CONFIRMED THE ONE RETURNED USED CATHETER BALLOON WAS TORN/DAMAGED. THERE WERE NO VISUAL ABNORMALITIES DETECTED WITH THE PKGD 41239-06 SAME LOT SAMPLE. ENGINEERING TESTING AND ANALYSIS OF THE ONE PKGD 41239-06 CATHETER RECORDED THE DEVICE MET ALL PERFORMANCE AND PRODUCT SPECS. USING AN IN-HOUSE SAMPLE CATHETER, ADD'L ANALYSIS WITH THE RETURNED AVANTI INTRODUCER ANCILLARY DEVICE WAS PERFORMED. THE RESULTS RECORDED NO CATHETER BALLOON TEARS, DAMAGES OR ABNORMALITIES. AS PART OF ICU MEDICAL'S CONTINUOUS IMPROVEMENT INITIATIVES A MULTI-DISCIPLINE TEAM WAS INITIATED TO PERFORM IN-DEPTH ANALYSIS OF THIS ISSUE; DETERMINE THE ROOT CAUSE(S) AND IMPLEMENT APPROPRIATE CORRECTIVE ACTIONS. ADD'L ENGINEERING INVESTIGATIONS AND ANALYSIS ARE IN PROGRESS. STATUS OF THE ACTIVITIES INCLUDE: FUNCTIONAL DATA OBTAINED FROM PRODUCTION LOTS AND ENGINEERING STUDIES WERE REVIEWED. NO TRENDS/FAILURES IN PERFORMANCE WERE FOUND. A REVIEW OF RAW MATERIAL DATA WAS CONDUCTED. THE ANALYSIS NOTED THAT NEW LOTS OF THE BALLOON MATERIAL (POLYISOPRENE) ARE RECEIVED EVERY 6 MONTHS, BUT CONSUMPTION CAN VARY BASED ON SALES/MARKET NEEDS. POTENTIAL ROOT CAUSE: POLYISOPRENE IS CONTINUALLY AGING, BALLOONS MANUFACTURED WITH OLDER MATERIAL, WHEN SUBJECTED TO CERTAIN CONDITIONS (SHIPPING, HEAT, ETC.) MAY EXPERIENCE MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: VISUAL ANALYSIS OF THE ONE USED 41239-06 CONFIRMED INFLATION FAILURE DUE TO BALLOON TEARS/DAMAGES. TESTING OF THE ONE RETURNED SAME LOT PACKAGED SAMPLE RECORDED NO PERFORMANCE ISSUES AND OR OUT OF SPEC CONDITIONS. THE EXACT CAUSE OF THE REPORTED PRODUCT ISSUE IS UNK AT THIS TIME.

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING A CATHETER BALLOON INFLATION PROBLEM WITH USE OF ONE 41239-06 TD CATHETER. THE CATHETER DEVICE WAS SUCCESSFULLY PRE-TESTED AND PLACED USING CORDIS/AVANTI 8FR, 11CM INTRODUCER/SHEATH. AT SOME UNSPECIFIED TIME DURING THE PROCEDURE, THE INFLATED CATHETER BALLOON LOST INFLATION. ATTENDING CLINICIAN "WAS NOT INFLATING AT THE TIME...". THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14120 TD TORQUE LINE CATHETER CATHETER FOZ ICU MEDICAL, INC. 41239-06 18-917-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 CORDIS SHEATH| 11CM INTRODUCERS| AVANTI 8FR