BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 6383650 · Received March 7, 2017

    Report

    Report Number
    1820334-2017-00440
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    February 6, 2017
    Report Date
    May 8, 2017
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002183711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, TRENDS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND TWO NON-CONFORMANCES WERE NOTED. NEITHER NON-CONFORMANCE WAS RELATED TO THE PROBLEM REPORTED. THE COMPLAINT HISTORY WAS REVIEWED AND INDICATED THIS IS THE ONLY COMPLAINT OF THIS NATURE ON THIS SPECIFIC LOT. THE VISUAL INSPECTION OF THE RETURNED DEVICE REPORTED THE FOUR REQUIRED MARKER BANDS ARE PRESENT AND SECURE. IN THE DEVICES' CURRENT STATE, THE DISTAL TIP MEASURED 4MM IN LENGTH. THE ALLEGED SEPARATED TIP SEGMENT WAS NOT SUBMITTED FOR EVALUATION. NO ASSIGNABLE CAUSE AND/OR ANOMALIES ASSOCIATED AT MANUFACTURING AND PACKAGING PROCESSES OF THE PRODUCT WHICH COULD CONTRIBUTE AND/OR BE RELATED WITH REPORTED INCIDENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO EVIDENCE WAS FOUND INDICATING THAT THE DEVICE WAS MANUFACTURED OUTSIDE OF COOK INC. SPECIFICATIONS. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # : K122796. THE REPORTED DEVICE HAS BEEN RECEIVED, AN EVALUATION IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE CXI SUPPORT CATHETER WAS NOTICED TO BE STICKY AFTER BEING LOADED ONTO THE WIRE. THE CATHETER WAS REMOVED AND THE MARKER BAND TIP OF THE CATHETER CAME OFF AND REMAINED STUCK ON THE WIRE. THIS OCCURRED BEFORE PATIENT CONTACT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167663 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC N/A 00827002183711

    Patients

    Seq Age Sex Outcome Treatment
    1