BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIQ, SVO2/CCO CATHETER

    MDR report key: 5225009 · Received November 16, 2015

    Report

    Report Number
    2025816-2015-00117
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    June 23, 2015
    Report Date
    December 4, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQE
    PMA / PMN Number
    K06299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS: 11/2/2015 - RECEIVED ONE (1) USED 52510-14, 8F OPTIQ, SVO2/CCO J-TIPPED CATHETER LOT# 2829041. A TOUCH CONTAMINATION SHIELD AND A Y-SITE ADAPTER WERE ADDED TO THE CATHETER WHICH A COVERS THE CATHETER FROM APPROXIMATELY THE 10CM MARK TO THE 90CM MARK. BLOOD WAS VISIBLE ON THE CATHETER AND IN THE Y-SITE ADAPTER. TEST RESULTS: CATHETER WAS VISUALLY INSPECTED AND THEN WAS WORKED FOR ACTUATION THROUGH INTRODUCER AND CONTAMINATION SHEATH. THROUGH CAREFUL INSPECTION THE CATHETER TUBING WAS INSPECTED NO KINKS OR ANOMALIES WERE OBSERVED. UPON RECEIPT IT WAS OBSERVED THAT THE CATHETER COULD NOT MOVE BACK AND FORTH THROUGH THE INTRODUCER AND SHEATH. IT WAS OBSERVED THAT THE TWISTING CONNECTION OF BOTH ENDS OF THE CONTAMINATION SHEATH WERE TIGHTENED TO NOT ALLOW MOVEMENT OF THE CATHETER. ONCE THE TWISTING CONNECTION WAS LOOSENED THAT CATHETER WAS ABLE TO EASILY SLIDE BACK AND FORTH THROUGH THE INTRODUCER AND CONTAMINATION SHEATH. UNIT WAS ALSO LEAK TESTED AND FLOW TESTED. NO LEAKING WAS OBSERVED DURING LEAK TESTING. FLOW RATE FOR DISTAL LUMAN WAS 3.77 ML/MIN PROXIMAL LUMEN WAS 9.37 ML/MIN AND DTP LUMEN WAS 3.66 ML/MIN. EACH FLOW RATE FOR ALL THREE LUMEN PASSED SPECIFICATION TESTING. BALLOON WAS INFLATED AND INSPECTED FOR SYMMETRY AND LEAKING. BALLOON PASSED ALL INSPECTIONS FOR INFLATION, DEFLATION,SYMMETRY, AND DIAMETER (0.527IN) REQUIREMENTS. CATHETER LUMEN DIAMETER WAS MEASURED. NO FAILURE WAS OBSERVED. CATHETER LUMEN PASSED SPECIFICATION TESTING. ANALYSIS SUMMARY: THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. IT IS UNCLEAR IF THE CATHETER WAS UNABLE TO ADVANCE DUE TO THE TIGHTENED CONNECTIONS OF THE CONTAMINATION SHEATH OR FROM SOME DIFFICULTY OF THE PATIENT'S ANATOMY. THE DIFFICULTY OF INSERTION COULD NOT BE CONTRIBUTED TO ANY FUNCTIONAL PERFORMANCE OF THE CATHETER.

    Description of Event or Problem · 1

    INT'L (B)(6) COMPLAINT RECEIVED REPORTING PLACEMENT DIFFICULTIES WITH USE OF ONE (1) 52510-14, 8F OPTIQ, SVO2/CCO J-TIPPED CATHETER. THE INITIAL INFORMATION RECEIVED REPORTS AT AN UNSPECIFIED TIME DURING THE PROCEDURE DOCTOR WAS " UNABLE TO ADJUST ADVANCEMENT, HAD TO REMOVE THE WHOLE CATHETER". THE 52510-14 CATHETER WOULD HAVE BEEN PRE-TESTED PRIOR TO PLACEMENT. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL RELEVANT EVENT/USAGE INFORMATION ALTHOUGH REQUESTED BY THE MANUFACTURER HAS NOT BEEN PROVIDED. DEVICE RETURN: ONE USED 52510-14 CATHETER WAS RECEIVED. QE INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756836 OPTIQ, SVO2/CCO CATHETER OPTIQ, SVO2/CCO CATHETER DQE ICU MEDICAL, INC. 52510-14 2829041

    Patients

    Seq Age Sex Outcome Treatment
    1