BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD CATHETER

    MDR report key: 3049577 · Received March 13, 2013

    Report

    Report Number
    2025816-2013-00016
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT RECORD REVIEWS: (B)(4). THE LOT BUILD REVIEW VERIFIED THE BALLOONS WERE 100% TESTED AND INSPECTED DURING THE MANUFACTURING PROCESSES AND PRIOR TO PACKAGING. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. CONCLUSION: VISUAL ANALYSIS OF THE RETURNED USED 41229-01 CATHETERS CONFIRMED THE REPORTED BALLOON INFLATION PROBLEM DUE TO TEARS/DAMAGES TO THE CATHETER BALLOON. ALTHOUGH THE EXACT CAUSE OF THE REPORTED PRODUCT ISSUE IS UNKNOWN, THE MOST LIKELY CAUSE WAS DUE TO USAGE WHERE INCORRECT TECHNIQUE OR USE OF INCORRECT/INCOMPATIBLE ANCILLARY ACCESSORY DEVICES. THESE FINDINGS WERE PROVIDED TO THE DISTRIBUTOR TO PROVIDE FEEDBACK TO THE FACILITY. THE MFGER. WILL CONTINUE TO MONITOR AND TREND THESE TYPES OF ISSUES.

    Description of Event or Problem · 1

    INT'L ((B)(6)) COMPLAINT REC'D REPORTING 41239-06 TD CATHETER BALLOON INFLATION PROBLEM. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. ALTHOUGH THE MANUFACTURER REQUESTED ADDITIONAL RELEVANT INFORMATION AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE. MFR'S. INVESTIGATION AND ANALYSIS: DEVICE RETURN: ONE USED 41229-01 TD CATHETER WAS RETURNED FOR ANALYSIS AND INVESTIGATION. VISUAL INSPECTION CONFIRMED THE RETURNED CATHETER BALLOON TEARS NEAR THE DISTAL SEAL OF THE BALLOON. THIS CONDITION WOULD RESULT IN INFLATION FAILURE. ENGINEERING ANALYSIS: PREVIOUS INVESTIGATIONS OF THESE TYPES OF TEARS HAVE DOCUMENTED THIS TO BE ATTRIBUTABLE TO THE USE OF INCORRECT SIZED ANCILLARY DEVICES SUCH AS INTRODUCERS, SHEATH ADAPTORS. THE CATHETER LABELED DIRECTIONS FOR USE (DFU) PROVIDE DETAILED INSTRUCTIONS ON THE USE OF INTRODUCERS AND CONTAMINATION SHIELDS. ENSURING THAT ALL TECHNIQUES AND EQUIPMENT ARE IN LINE WITH THE DFU WILL REDUCE THE LIKELIHOOD OF THIS OCCURRING IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106681 TD CATHETER CATHETER DYG ICU MEDICAL, INC. 41229-01 04-567-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER AND SHEATH MFGER. MAKE & MODEL UNKNOWN.