BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN-END URETERAL CATHETER

    MDR report key: 9680769 · Received February 7, 2020

    Report

    Report Number
    1820334-2020-00302
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    January 3, 2020
    Report Date
    March 27, 2020
    Manufacturer
    COOK INC
    Product Code
    KOD
    UDI-DI
    00827002148185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN OPEN-END URETERAL CATHETER WAS OBSERVED TO BE KINKED AND CRACKED. THE CATHETER SEPARATED WHILST BEING INSPECTED AFTER BEING REMOVED FROM THE PATIENT. THE CATHETER WAS BEING USED FOR A CYSTOSCOPY PROCEDURE USING A 9.5 FRENCH CYSTOSCOPE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS EVENT. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND QUALITY CONTROL DATA. ONE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL EXAMINATION CONFIRMED A CATHETER WAS RETURNED IN TWO SEGMENTS AND IN USED CONDITION. THE CATHETER WAS SEVERED 2.5CM FROM THE DISTAL TIP. THE POINT OF SEPARATION WAS CUT AT AN ANGLE WITH MATING FRACTURES. WHITE STRESS MARKS ARE VISIBLE ON AND NEAR THE POINT OF SEPARATION INDICATING THE CATHETER WAS CUT AND PULLED TO SEPARATION. THE WHITE STRESS MARK WAS VISIBLE ALONG THE CIRCUMFERENCE OF THE CATHETER LOCATED 1MM FROM 3RD INK BAND, WHERE THE CATHETER WAS POSSIBLY KINKED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE DEVICE IS NOT SUPPLIED WITH INSTRUCTIONS FOR USE. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. COOK HAS CONCLUDED THAT AN UNINTENDED USE ERROR LIKELY CONTRIBUTED TO THE FAILURE MODE BASED ON THE DAMAGE TO THE RETURNED DEVICE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: DEPARTMENT ASSISTANT, CENTRAL SERVICE. PMA/510K #: K171662. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING A CYSTOSCOPY PROCEDURE, AN OPEN-END URETERAL CATHETER WAS USED TO OBTAIN ACCESS INTO A URETER. WHEN THE CATHETER WAS REMOVED, A KINK AND CRACK IN THE CATHETER WAS NOTICED. WHEN EXAMINING THE CATHETER, IT WAS ALMOST COMPLETELY BROKEN AND THEN BROKE COMPLETELY SHORTLY AFTER. THERE WAS NO AFFECT ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143326 OPEN-END URETERAL CATHETER KOD CATHETER, UROLOGICAL KOD COOK INC G14818 10145976 00827002148185

    Patients

    Seq Age Sex Outcome Treatment
    1