BEUDAMED
    FDA Adverse Event Other Summary report: N

    TD TORQUE-LINE CATHETER (HEPARIN AND NON HEPARIN

    MDR report key: 3311040 · Received August 16, 2013

    Report

    Report Number
    2025816-2013-00082
    Event Type
    Other
    Date Received
    August 16, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: DEVICE RETURN STATUS: THE INVOLVED CATHETER DEVICES WERE NOT RETURNED FOR ANALYSIS AND INVESTIGATION. METHOD: ENGINEERING ANALYSIS: SIX (6) TD CATHETER FROM FINISHED GOODS WERE OBTAINED AND TESTED PER THE TD EXTRUSION RADIAL RIGIDITY REQUIREMENTS (CATHETER STIFFNESS). THE ENGINEERING REPORT NOTED THE SAMPLE CATHETERS WERE ALL TESTED WITH THE THERMISTOR WIRE INSIDE THE THERMISTOR LUMEN. THE THERMISTOR WIRE WOULD BE EXPECTED TO INCREASE STIFFNESS. THE VALUES OBTAINED ALIGNED WITH EXPECTED STIFFNESS AND WERE ACCEPTABLE. THE TEST DATA INDICATED ALL SIX SAMPLE CATHETERS MET THE RIGIDITY PRODUCT SPECIFICATION. RECORD AND COMPLAINT TRENDING REVIEWS: A REVIEW OF THE COMPLAINT DATABASE FOR THESE LIST#/SIMILAR INCIDENTS RECORDED NO ADDITIONAL REPORTS OR TRENDS. THE MANUFACTURERS PRODUCT REPRESENTATIVES AND CLINICAL SUPPORT PERSONNEL HAVE CONDUCTED MULTIPLE SITE VISITS AND PERFORMED DETAILED IN-SERVICING WITH FACILITY STAFF. CONCLUSION: THE INVOLVED CATHETER DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THERE WERE NO REPORTED DEVICE/COMPONENT DEFECTS. FACILITY MEDICAL STAFF HAVE ACKNOWLEDGED THAT INSERTION/PLACEMENT ISSUES ARE A KNOWN INHERENT RISK WITH MANY CONTRIBUTING FACTORS INCLUDING TECHNIQUE, PATIENT ANATOMICAL CONDITIONS ETC. THE EXACT CAUSE(S) OF THESE INCIDENTS IS UNKNOWN BUT IS MOST LIKELY THE RESULT OF USAGE/TECHNIQUE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING INSERTION/PLACEMENT ISSUES WITH USE OF 41237-05 TD HEPARIN COATED AND 41237-06 NON-HEPARIN TD CATHETERS. IT WAS REPORTED THAT "..DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE ATTENDING CLINICIAN WAS POSITIONING/ADVANCING THE 41237-05 TD 8 FR. CATHETER WHEN "PUNCTURED THE PATIENTS MYOCARDIUM". FOLLOW UP MEETINGS WITH INVOLVED CLINICAL STAFF IDENTIFIED A PREVIOUS INCIDENT THAT OCCURRED IN (B)(6) 2012 WITH USE OF 41237-06 CATHETER. STAFF WERE UNABLE OR UNWILLING TO PROVIDE ADD'L. INFORMATION, DETAILS OR DEVICE STATUS FOR THAT INCIDENT. IT WAS ALSO ACKNOWLEDGED THAT BOTH DEVICES WERE PRE-TESTED WHERE NO ISSUES WERE ENCOUNTERED. THERE WERE NO SPECIFIC AND OR IDENTIFIABLE DEVICE/COMPONENT DEFECTS IDENTIFIED DURING THEIR INTERNAL INVESTIGATION OF THESE INCIDENTS AS WELL AS PREVIOUS ONES WITH USE OF ANOTHER MFR'S., CATHETERS. THE FACILITY CLINICAL STAFF CONFIRMED THERE WERE NO ADVERSE PT. CONSEQUENCES ASSOCIATED WITH EITHER INCIDENTS. BOTH PATIENTS DIAGNOSED CONDITIONS WERE SUCCESSFULLY TREATED PER STANDARD PROCEDURES AND TREATMENTS. BOTH PATIENTS DID NOT REQUIRE ADDITIONAL HOSPITALIZATION, WERE TREATED AND SUBSEQUENTLY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396448 TD TORQUE-LINE CATHETER (HEPARIN AND NON HEPARIN PA TD CATHETER DRS ICU MEDICAL INC. 41237-05 AND -06 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI