BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICATH CVO CATHETER EXPANDED KIT

    MDR report key: 3786335 · Received March 27, 2014

    Report

    Report Number
    2025816-2014-00038
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    February 1, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ICU MEDICAL,INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: ONE (1) GUIDEWIRE FROM THE 50456-01 OPTICATH EXPANDED KIT 02 TD CATHETER WAS RETURNED. THE INVOLVED CATHETER AND ACCESSORY DEVICES WERE NOT RETURNED. MFRS INVESTIGATION: VISUAL INSPECTION AND ANALYSIS OF THE RETURNED 50456-01 EXPANDED KIT GUIDEWIRE RECORDED THE ACCESSORY DEVICE WAS DAMAGED/UNRAVELED. THE ENGINEERING REPORT NOTED THE WIRE COIL SEPARATED FROM THE INNER WIRE. ENGINEERING DISCUSSION: A CATHETER GUIDEWIRE IS A COILED WIRE THAT IS DESIGNED TO FIT INSIDE A CATHETER FOR THE PURPOSE OF GUIDING AND PLACEMENT INTO THE VASCULAR SYSTEM. USAGE REQUIRES A COMPATIBLE ENTRY NEEDLE WHOSE LUMEN WILL ACCOMMODATE THE GUIDEWIRE AND AN INTRODUCER OR CATHETER WHOSE LUMEN WILL ALLOW PASSAGE OVER THE GUIDEWIRE. MFG LOT BUILD RECORD REVIEW: A REVIEW OF THE SUSPECTED LOT# 34-589-HE (MFG DATE 12/2013) SHOWS (B)(4) UNITS WERE MFG, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG LOT BUILD PROCESSES. ADD'L RECORD REVIEWS: THIS GUIDEWIRE IS A PURCHASED OEM DEVICE THAT IS PROVIDED IN THE 50456-01 CATHETER EXPANDED KIT. THE GUIDEWIRE SPECIFICATIONS INCLUDE BUT NOT LIMITED TO THE MATERIAL PROPERTIES, DIMENSIONAL ATTRIBUTES ETC. THAT MEET INDUSTRY STANDARDS. THESE GUIDEWIRES ARE 100% INSPECTED DURING INCOMING INSPECTION AS WELL AS TESTED AND INSPECTED THROUGHOUT THE ASSEMBLY PROCESSES. FINDINGS: BASED ON THE VISUAL INSPECTION OF THE "AS-REC'D" GUIDEWIRE THE REPORTED DAMAGE WAS VISUALLY CONFIRMED. BASED ON THE "AS REC'D" CONDITION THE RETURNED GUIDEWIRE WAS MOST LIKELY SUBJECTED TO EXCESSIVE BENDING AND KINKING AND SOME DEGREE OF EXCESSIVE FORCE DURING REMOVAL.

    Description of Event or Problem · 1

    COMPLAINT REC'D CONCERNING COMPONENT ACCESSORY (GUIDEWIRE) ISSUES WITH USE OF 50456-01 OPTICATH CVO CATHETER EXPANDED KITS. IT WAS REPORTED THAT THE FACILITIES DOCTORS FIND ".. THAT THIS PARTICULAR GUIDEWIRE IS "TOO FLIMSY." ONE RECENT PT INCIDENT REPORTED DURING CENTRAL LINE INSERTION "..THIS PARTICULAR ONE "SHREDDED" WHILE THE DOCTOR WAS TRYING TO INSERT THE WIRE INTO THE PT." THE CATHETER DEVICES WERE REMOVED AND REPLACED WITH NO FURTHER INCIDENT. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182458 OPTICATH CVO CATHETER EXPANDED KIT CATHETER FPA ICU MEDICAL,INC. 50456-01 34-589-HE

    Patients

    Seq Age Sex Outcome Treatment
    1 NI