BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD TORQUE LINE CATHETER

    MDR report key: 2956613 · Received January 10, 2013

    Report

    Report Number
    2025816-2012-00114
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    October 9, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    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 WERE RETURNED. VISUAL INSPECTION CONFIRMED THE ONE RETURNED USED CATHETER BALLOON WAS TURN/DAMAGED. THERE WERE NO VISUAL ABNORMALITIES DETECTED WITH THE PKGD 41239-06 SAME LOT SAMPLE. ENGINEERING TESTING AND ANALYSIS OF THE UNUSED 41239-06 CATHETER RECORDED THE BALLOON CYCLE BURST TESTING DID NOT MEET THE SPECS. A REVIEW OF THE MFG LOT DATABASE FOR LOT #18-387-SJ (MFG DATE 07/2012) SHOWS 215 UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG BUILD CYCLE. 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 ALSO REPLICATED THE INFLATION ISSUE. THE EXACT CAUSE OF THE REPORTED PRODUCT ISSUE IS UNK AT THIS TIME.

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING CATHETER BALLOON INFLATION PROBLEMS WITH USE OF (TWO) 41239-06 TD CATHETERS. THE (B)(6) /2012, INCIDENT WAS REPORTED AS FOLLOWS ".. WHILE TRYING TO CROSS THE TRICUSPID VALVE, WE HAD A BALLOON RUPTURE...". THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14118 TD TORQUE LINE CATHETER CATHETER DYG ICU MEDICAL, INC. 41239-06 18-387-SJ; UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 AVANTI 8FR INTRODUCER/SHEATH