BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN-END FLEXI-TIP URETERAL CATHETER

    MDR report key: 9675851 · Received February 6, 2020

    Report

    Report Number
    1820334-2020-00295
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 30, 2020
    Report Date
    March 4, 2020
    Manufacturer
    COOK INC
    Product Code
    KOD
    UDI-DI
    00827002145214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EC METHOD CODE DESC - 5: COMMUNICATION/INTERVIEWS (4111). INVESTIGATION ¿ EVALUATION: ON 30JAN2020, BLUEWATER HEALTH INFORMED COOK OF AN EVENT INVOLVING A OPEN-END FLEXI-TIP URETERAL CATHETER (RPN: 021305) OF LOT 10209156. THE OPEN-ENDED CATHETER WAS USED DURING THE PROCEDURE AND PLACED WITH A WIRE GUIDE. THE WIRE GUIDE WAS REMOVED WITHOUT INCIDENT. THE PATIENT ASKED THE PHYSICIAN TO SEE HER BLADDER ON THE MONITOR. WHEN THE PATIENTS BLADDER WAS VIEWED, THE END OF THE CATHETER WAS DISCOVERED IN BLADDER. TO CORRECT THE ISSUE, THE TIP AND CATHETER WERE SUCCESSFULLY REMOVED WITH A SEMI-RIGID GRASPER. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT-BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, SPECIFICATIONS, AND QUALITY CONTROL DATA. THE COMPLAINANT RETURNED ONE USED AND 13 UNOPENED 5 FR OPEN-END FLEXI-TIP URETERAL CATHETER FOR INVESTIGATION. VISUAL EXAMINATION CONFIRMED A CATHETER WAS RETURNED IN USED CONDITION. THE LENGTH OF CATHETER WAS 69.5CM. THE CATHETER WAS RETURNED IN TWO PIECES. THE FLEXIBLE TIP WAS SEPARATED FROM THE DISTAL TIP, AND THE POINT OF SEPARATION OCCURRED ABOVE THE FIRST INK BAND. THE LENGTH OF THE FLEXIBLE TIP MEASURED 8MM AND WAS WITHIN SPECIFICATION TOLERANCE OF 6MM-9MM. THE POINT OF SEPARATION HAS OCCURRED WHERE THE TWO PIECES OF MATERIAL ARE BONDED TOGETHER. ALSO, THERE WERE THIRTEEN UNUSED DEVICES RETURNED AND EACH WAS OPENED FOR EXAMINATION. EACH CATHETER WAS FLEXED 5 TIMES IN DIFFERENT DIRECTION, THE BONDS WERE STRONG, AND THE FLEXIBLE TIP REMAINED SECURELY BONDED TO THE CATHETER. THE RETURNED SAMPLES WERE WITHIN SPECIFICATION. EIGHT CATHETERS FROM THIS LOT WERE TEST PULLED AND PASSED THE MINIMUM TEST PULL CRITERIA OF 3.5LBS, EACH SAMPLE PULLED OVER 4LBS WITH A MINIMUM BREAK OF 4.519 LBS. AND MAXIMUM BREAK 5.917LBS. THE BREAK LOCATION OF ALL CATHETERS WERE AT THE BOND. THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES THAT MAY HAVE CONTRIBUTED TO THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) 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. A DEFINITIVE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL 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 SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT: ADDRESS: POSTAL CODE: (B)(6). OCCUPATION: OTHER NON-HEALTHCARE PROFESSIONAL: PN7T 6S3ERIOPERATIVE SUPPLY CHAIN SPECIALIST. 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 THAT DURING A STENT PLACEMENT UNDER LOCAL ANESTHESIA, A OPEN-END FLEXI-TIP URETERAL CATHETER WAS IN USE WHEN ITS TIP DETACHED WITHIN THE PATIENT'S BLADDER. THE TIP OF THE CATHETER WAS REMOVED WITH SEMI-RIGID GRASPERS DURING THE CASE. NO PORTION OF THE DEVICE REMAINED WITHIN THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142426 OPEN-END FLEXI-TIP URETERAL CATHETER KOD CATHETER, UROLOGICAL KOD COOK INC G14521 10209156 00827002145214

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR 21FR RIGID CYSTOSCOPE, STRAIGHT SENSOR GW