BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISTLE TIP URETERAL CATHETER

    MDR report key: 9495310 · Received December 19, 2019

    Report

    Report Number
    1820334-2019-03151
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Report Date
    February 24, 2020
    Manufacturer
    COOK INC
    Product Code
    KOD
    UDI-DI
    00827002140288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION EVALUATION: IT WAS REPORTED THAT THE TIP OF A WHISTLE TIP URETERAL CATHETER (PART NUMBER 022103) FROM LOT NUMBER (9873789) SEPARATED DURING A CYSTOSCOPY. THE SEPARATED TIP WAS RETRIEVED FROM THE PATIENT USING GRASPERS. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM AS A RESULT OF THIS CASE. COOK REPRESENTATIVES MADE MULTIPLE ATTEMPTS TO GET THE DEVICE RETURNED AND ADDITIONAL INFORMATION ABOUT THE CASE BUT THE CUSTOMER DID NOT RESPOND. A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND, QUALITY CONTROL DATA. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. 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. AS THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. 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. A REVIEW OF THE NORTH AMERICA DISTRIBUTION CENTER FOUND THERE WAS NO STOCK REMAINING OF LOT 9873789 FOR EVALUATION. THERE IS NOT ENOUGH EVIDENCE AVAILABLE TO MAKE A CONCLUSIVE DETERMINATION OF THE CAUSE. COOK HAS CONCLUDED THE CAUSE IS NOT ESTABLISHED. 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 ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    OCCUPATION: OR CLINICAL COORDINATOR. 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 AN CYSTOSCOPY PYELOGRAM OF THE BLADDER USING A WHISTLE TIP URETERAL CATHETER, THE CATHETER TIP DETACHED INSIDE OF THE PATIENT. AS THE CATHETER WAS BEING WITHDRAWN, A PIECE OF THE CATHETER WAS NOTED TO BE MISSING. THE PIECE WAS SUCCESSFULLY RETRIEVED WITH GRASPERS. THERE WAS NO HARM TO THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292821 WHISTLE TIP URETERAL CATHETER KOD CATHETER, UROLOGICAL KOD COOK INC G14028 9873789 00827002140288

    Patients

    Seq Age Sex Outcome Treatment
    1