BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SVO2 CCO OPTIQ CATHETER

    MDR report key: 3167983 · Received May 20, 2013

    Report

    Report Number
    2025816-2013-00035
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    February 17, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER/ SIMILAR ISSUE DID NOT IDENTIFY ANY ADDITIONAL REPORTS OR INVESTIGATIONS IDENTIFYING A MANUFACTURING DEFECT/ NON-CONFORMANCE. (B)(4). THERE WERE NO EXCEPTION OR REJECTION DOCUMENTS GENERATED DURING THE BUILD. THE 52509-14 CATHETER DFU PRECAUTION STATEMENT NOTES "KNOTTING CAN OCCUR WITH ANY FLOW-DIRECTED PULMONARY ARTERY CATHETER. INSERTION OF A GUIDEWIRE INTO THE PA LUMEN AND MANIPULATION UNDER FLUOROSCOPY MAY BE SUCCESSFUL IN REMOVING A KNOT. IN SOME CASES, THE CATHETER CAN BE REMOVED IF THE KNOT IS PULLED TIGHT AND THE CATHETER IS GENTLY AND SLOWLY WITHDRAWN. IF AN INTRODUCER IS IN USE, A CATHETER KNOT SHOULD NOT BE PULLED THROUGH THE INTRODUCER. THE KNOT MAY BE WITHDRAWN TO THE INTRODUCER TIP AND THE CATHETER AND INTRODUCER REMOVED TOGETHER." CONCLUSION: BASED ON THE DIGITAL X-RAY PHOTOGRAPH PROVIDED BY THE FACILITY, THE REPORTED PRODUCT ISSUE WAS VISUALLY CONFIRMED. THE INVOLVED CATHETER WAS RETURNED TO THE MFR WHERE VISUAL INSPECTION OF THE "AS-RECEIVED" CATHETER AS WELL AS THOROUGH TESTING AND ANALYSIS DID NOT IDENTIFY A MANUFACTURING DEFECT, NON-CONFORMANCE AND OR PERFORMANCE ISSUE THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PRODUCT EXPERIENCE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING ONE (1) 52509-14 OPTIQ CATHETER KNOTTED/KINKED FOLLOWING PLACEMENT. THE REPORT STATES " CATHETER WAS KINKED ONCE IMPLANTED AND THIS WAS VERIFIED WITH AN X-RAY." THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. DEVICE RETURN: ONE (1) USED 52509-14 OPTIQ, SV02/CCO CATHETER, 8, 110CM, Q-TIP, HEPARIN COATED; LOT # 2557463 WAS RETURNED FOR ANALYSIS AND INVESTIGATION. PRE-DECONTAMINATION ANALYSIS WAS PERFORMED. THE RESULTS RECORDED LIQUID/ FLUID WAS PRESENT IN THE BALLOON LUMEN. THERE WAS NO VISUAL EVIDENCE OF KINKING OR KNOTTING. ENGINEERING TESTING AND ANALYSIS WAS PERFORMED. THE RESULTS RECORDED NO DIMENSIONAL NON-CONFORMANCES; FUNCTIONAL TESTING INCLUDING LUMEN FLOW RATES RECORDED THE CATHETER MET PRODUCT SPECIFICATION, LEAK TESTS RECORDED NO LEAKS AND/OR OUT OF SPECIFIC CONDITIONS; TESTING AND ANALYSIS OF THE CATHETER EXTRUSION FOUND THE COMPONENT MATERIAL STIFFNESS WAS WITHIN THE SPECIFICATION REQUIREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223197 SVO2 CCO OPTIQ CATHETER SVO2 CCO CATHETER DQE ICU MEDICAL, INC. 52509-14 2557463

    Patients

    Seq Age Sex Outcome Treatment
    1