BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN-END URETERAL CATHETER

    MDR report key: 9417932 · Received December 5, 2019

    Report

    Report Number
    1820334-2019-03018
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    October 30, 2019
    Report Date
    February 7, 2020
    Manufacturer
    COOK INC
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 SEGMENT OF THE CATHETER WAS RETURNED. THE SEGMENT MEASURED 2.5CM LONG AND INCLUDED TWO BLACK INK BANDS. ONE END OF THE SEGMENT HAD A ROUNDED EDGE. THE OPPOSITE END HAS AN ANGULAR CUT AND WAS STRETCHED AT THE END INDICATING THE CATHETER WAS CUT THEN PULLED TO SEPARATION. THE TUBING WAS KINKED APPROXIMATELY 9MM FROM THE ROUNDED TIP. BASED ON THE APPEARANCE OF THE RETURNED SPECIMEN, SEGMENT WAS THE DISTAL TIP OF THE CATHETER. THE REMAINING LENGTH OF THE CATHETER AND THE 050010 ADAPTER WERE NOT RETURNED. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE TORN DISTAL SECTION ONLY OF A OPEN END URETERAL CATHETER WAS RETURNED. THE TORN END WAS 2.5 CM LONG. THE TORN END OF THE CATHETER WAS FOUND TO HAVE A ANGULAR CUT, INDICATING IT WAS POSSIBLE THE CATHETER WAS CUT THEN PULLED TO SEPARATION. THERE WAS ALSO A KINK 9MM FROM THE DISTAL END OF THE CATHETER. THE INFORMATION PROVIDED BY THE USER STATED THE ISSUE OCCURRED DURING PLACEMENT OF THE CATHETER, NOT REMOVAL. THERE WAS ALSO INFORMATION PROVIDED THAT THERE MAY HAVE BEEN A FIT ISSUE WITH THE SIZE OF SCOPE BEING USED IN THE PROCEDURE. IT WAS DETERMINED, BASED ON THE KNOWN EVIDENCE, THAT IT WAS MOST LIKELY THE CATHETER BECAME CAUGHT ON A PORTION OF THE SCOPE DURING PLACEMENT OF THE CATHETER AND WAS SUBSEQUENTLY CUT AND TORN, SEPARATING THE DISTAL 2.5CM FROM THE REMAINDER OF THE CATHETER. THE CAUSE FOR THE ISSUE WAS AN INADVERTENT USER ERROR. 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

    (B)(6). 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 AN URETEROPYELOSTOMY AND ANASTOMOSIS OF URETER, ON (B)(6) 2019, A 3 FR OPEN-END URETERAL CATHETER WAS PLACED IN THE LEFT URETERAL ORIFICE THROUGH A 5 FR ANGLED PEDIATRIC CYSTOSCOPE. A RETROGRADE INSTILLATION OF CONTRAST SHOWED A NORMAL URETER TO THE LEVEL OF THE URETEROPELVIC JUNCTION. PROXIMAL TO THIS POINT THE URETER WAS SIGNIFICANTLY NARROWER WITH HYDRONEPHROSIS. THE STENT WAS THEN ADVANCED INTO THE RENAL PELVIS, WHERE A 0.018 GUIDEWIRE WAS PLACED THROUGH IT INTO THE PELVIS. THE OPEN-ENDED STENT WAS THEN REMOVED AND A 14 CM, 3 FR DOUBLE-J CATHETER WAS PLACED OVER THE GUIDEWIRE INTO THE PELVIS. LOCATION WAS CONFIRMED WITH FLUOROSCOPY. AN 8 FR FOLEY CATHETER WAS THEN PLACED WITH RETURN OF CLEAR URINE. ON (B)(6) 2019, AN X-RAY FOUND A FOREIGN BODY IN THE LEFT URETER. THERE WAS NO WAY TO DEFINITIVELY IDENTIFY WHAT THE OBJECT WAS, SO IT WAS DECIDED TO WAIT UNTIL THE PLANNED STENT REMOVAL TO REMOVE THE FOREIGN BODY. ON (B)(6) 2019, THE PATIENT RETURNED FOR PLANNED STENT REMOVAL, THE UNIDENTIFIED OBJECT WAS REMOVED IN ITS ENTIRETY AND SENT TO THE LAB. IT WAS DETERMINED THAT IT WAS A PORTION OF THE OPEN-END URETERAL CATHETER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211863 OPEN-END URETERAL CATHETER KOD CATHETER, UROLOGICAL KOD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO