BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHISTLE TIP URETERAL CATHETER

    MDR report key: 17440077 · Received August 2, 2023

    Report

    Report Number
    1820334-2023-00991
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 25, 2023
    Manufacturer
    COOK INC
    Product Code
    KOD
    PMA / PMN Number
    K171662
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E3: CUSTOMER OCCUPATION: UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED."

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REPRESENTATIVE OF (B)(6) HOSPITAL REPORTED ON 12JUL2023 THAT A ¿WHISTLE TIP URETERAL CATHETER¿ [RPN: 022205; LOT UNKNOWN] WAS USED ON (B)(6) 2023 FOR AN EXPLORATORY LAPAROTOMY. THE DEVICE WAS PLACED CYSTOSCOPICALLY AT THE BLADDER AND NO OTHER DEVICES WERE USED CONCOMITANTLY. THERE WAS NO DIFFICULT ADVANCING THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT PRE-EXISTING CONDITIONS, ANATOMY, ETC. AS REPORTED, TOWARDS THE END OF THE PROCEDURE WHILE ATTEMPTING TO REMOVE THE DEVICE, THE TIP OF THE CATHETER BROKE OFF IN THE PATIENT'S URETER. THE USER RETRIEVED THE TIP WITH GRASPERS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES FOR THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. WITHOUT VISUAL, DIMENSIONAL, AND/OR FUNCTIONAL TESTING OF THE PRODUCT, WE ARE UNABLE TO DETERMINE IF THIS IS A MANUFACTURING ISSUE. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD OR SEARCH FOR OTHER COMPLAINTS FROM THE PRODUCT LOT DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. BECAUSE NO LOT RELATED EVIDENCE IS AVAILABLE AND ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE EVIDENCE FROM THE COMPLAINT FILE AND QUALITY CONTROL DOCUMENTS DEVICE INDICATES THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION AS WELL AS OTHER ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT IFU FOR THE CATHETER IS T_URECAT_REV1 WHICH INCLUDES THE FOLLOWING: PRECAUTIONS ¿ AVOID BENDING OR KINKING THE CATHETER PRIOR TO PLACEMENT. DOING SO COULD DAMAGE THE INTEGRITY OF THE CATHETER AND RESULT IN PATIENT INJURY. ¿ IF YOU ENCOUNTER RESISTANCE WHILE ADVANCING OR WITHDRAWING THE CATHETER, STOP. DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. ¿ DO NOT WITHDRAW CATHETER WHILE DEFLECTED IN CYSTOSCOPE/ENDOSCOPE. BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED. A REVIEW OF MANUFACTURING PROCEDURES FOUND CONTROLS TO BE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. A REVIEW OF THE IFU IDENTIFIED THAT IT INCLUDES THE FOLLOWING IN THE PRECAUTIONS ¿AVOID BENDING OR KINKING THE CATHETER PRIOR TO PLACEMENT. DOING SO COULD DAMAGE THE INTEGRITY OF THE CATHETER AND RESULT IN PATIENT INJURY.¿ DEVICE HANDLING PRIOR TO AND DURING PLACEMENT ARE UNKNOWN. IT WAS REPORTED THAT THE USER DID NOT HAVE DIFFICULTY WHILE ADVANCING THE DEVICE. THE IFU PRECAUTIONS ALSO INCLUDE "DO NOT WITHDRAW CATHETER WHILE DEFLECTED IN CYSTOSCOPE/ENDOSCOPE.¿ IT WAS REPORTED THAT A SCOPE WAS USED, AND THE DEVICE WAS PLACED CYSTOSCOPICALLY AT THE BLADDER. MANUFACTURER AND MODEL NUMBER OF THE SCOPE IS UNKNOWN. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    AS REPORTED, TOWARDS THE END OF THE PROCEDURE WHILE ATTEMPTING TO REMOVE A '¿WHISTLE TIP URETERAL CATHETER¿, THE TIP OF THE CATHETER BROKE OFF IN THE PATIENTS URETER DURING AN EXPLORATORY LAPAROTOMY. THE USER RETRIEVED THE TIP WITH GRASPERS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE WAS PLACED CYSTOSCOPICALLY AT THE BLADDER AND NO OTHER DEVICES WERE USED CONCOMITANTLY. THERE WAS NO RESISTANCE WHILE REMOVING THE STENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773407 WHISTLE TIP URETERAL CATHETER KOD CATHETER, UROLOGICAL KOD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNSPECIFIED SCOPE, GRASPERS