BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD TORQUE LINE CATHETER

    MDR report key: 3262369 · Received July 18, 2013

    Report

    Report Number
    2025816-2013-00075
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES RETURNED: ONE USED AND TWELVE PACKAGED 41231-06 TD TORQUE-LINE CATHETER LOT #24-114-HE WERE RETURNED FOR ANALYSIS AND INVESTIGATION. THE SJM INTRODUCER ACCESSORY DEVICE WAS NOT RETURNED. VISUAL INSPECTION AND ANALYSIS RECORDED NO OBVIOUS ABNORMALITIES. THE RETURNED USED 41231-06 CATHETER COMPONENT SURFACES DID NOT EXHIBIT ANY ABNORMAL SURFACE OR STIFFNESS/TENSION DEFECTS. ENGINEERING TESTING AND EVALUATIONS WERE PERFORMED. THE RESULTS RECORDED THE USED 41231-06 CATHETER AND THE RETURNED PACKAGED SAME LOT SAMPLES MET PRODUCT SPECS. ADD'L ANALYSIS OF THE CATHETER COMPONENTS MATERIAL ATTRIBUTES/STIFFNESS RECORDED THE CATHETERS WERE WITHIN THE PRODUCT SPEC. THE EXTRUSION OF THE CATHETER WAS ALSO INSPECTED VISUALLY AND TACTILELY FOR IRREGULARITIES DESCRIBED IN THE COMPLAINT, NO SUCH IRREGULARITIES WERE NOTED. MFG LOT BUILD RECORD REVIEW: A REVIEW OF THE MFG LOT DATABASE FOR LOT #24-114-HE (MFG DATE 01/2013) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. THE LOT BUILD REVIEW SHOWED ALL VISUAL AND FUNCTIONAL QC LOT TESTING MET SPECS. THERE WERE NO EXCEPTION OR REJECTION DOCUMENTS GENERATED DURING THE BUILD. CONCLUSION: THOROUGH TESTING AND ANALYSIS OF THE INVOLVED 41231-06 CATHETER AND THE RETURNED PACKAGED SAME LOT SAMPLES RECORDED NO MFG NON-CONFORMANCES OR OUT OF SPEC CONDITIONS. THERE WERE NO DEFECTS REPLICATED IN THE LABORATORY SETTING THAT WOULD CAUSE A KNOTTING OF THE CATHETER. THE CAUSE OF THE REPORTED PRODUCT EXPERIENCE IS UNK. THIS REPORT AND THE ASSOCIATED INFO HAVE BEEN STATUSED IN THE ICU MEDICAL INC DATABASE FOR MONITORING AND TRENDING.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED CONCERNING MULTIPLE ISSUES WITH USE OF ONE 41231-06 TD TORQUE LINE CATHETER. IT WAS REPORTED THAT AT AN UNSPECIFIED TIME DURING THE PROCEDURE ATTENDING CLINICIAN "COULD NOT TORQUE THE CATHETER... THE CATHETER CAUSED THE INTRODUCER TO "DOUBLE OVER" AND KINKED WHEN REMOVING THE CATHETER FROM THE PT". IT WAS ALSO REPORTED THAT ADD'L CONCERNS NOTED DURING PRE-TESTING AND INITIAL USE WHERE THE CATHETER WAS "TOO STIFF... HAD A DIFFICULT TIME SLIDING IT THROUGH THE SHEATH (ST JUDE MEDICAL ULTIMUM 7F-ACT, 7FR, 12CM) SOME TYPE OF SURFACE ABNORMALITY. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334008 TD TORQUE LINE CATHETER PA CATHETER DYG ICU MEDICAL, INC. 41231-06 24-114-HE

    Patients

    Seq Age Sex Outcome Treatment
    1 ST JUDE MEDICAL ULTIMUM 7F-ACT| 7FR, 12CM INTRODUCER