BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 18320958 · Received December 13, 2023

    Report

    Report Number
    1820334-2023-01697
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 27, 2023
    Report Date
    May 20, 2024
    Manufacturer
    COOK INC
    Product Code
    FAD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E3- OCCUPATION: LEAD TECH. G4 ¿ PMA/510(K) #: K171603. 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. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION IT WAS REPORTED THAT THE STIFFENER FROM AN ULTRATHANE COPE NEPHROURETEROSTOMY SET SEPARATED. THE DEVICE WAS PLACED IN THE PATIENT'S KIDNEY AND BLADDER ON (B)(6) 2023. NO ISSUES WERE NOTED DURING THE PROCEDURE. SEVENTEEN DAYS AFTER THE PROCEDURE, THE CATHETER WAS NOT DRAINING, SO THE PATIENT RETURNED TO THE FACILITY. AN ATTEMPT TO ADVANCE A DILATOR THROUGH THE CATHETER WAS UNSUCCESSFUL. IT WAS THEN DISCOVERED THAT A PORTION OF THE STIFFENER WAS RETAINED IN THE CATHETER. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A LIKE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE SUPPLIED BLUE FLEXIBLE STIFFENER FROM THE ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS RETURNED IN A USED AND DAMAGED CONDITION. THE FLEXIBLE STIFFENER WAS RETURNED IN THREE SECTIONS. THE O.D. OF THE FLEXIBLE STIFFENER AND I.D. OF THE CATHETER WERE CONFIRMED BE WITHIN SPECIFICATION. ADDITIONALLY, 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH TO THE CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. COOK ALSO REVIEWED PRODUCT LABELING. THE INSTRUCTIONS FOR USE (IFU) [T_NUCL_REV5] SUPPLIED WITH THE COMPLAINT LOT WERE REVIEWED FOR THE INFORMATION RELATED TO REPORTED FAILURE MODE. PER THE IFU: PRECAUTIONS A PTFE-COATED WIRE GUIDE MUST BE USED WITH THIS PRODUCT. ACTIVATE HYDROPHILIC COATING, IF PRESENT, BY WETTING SURFACE OF DEVICE WITH STERILE WATER OR SALINE. FOR BEST RESULTS, MAINTAIN WETTED CONDITION OF DEVICE DURING PLACEMENT. ¿INSTRUCTIONS FOR USE¿ 7. REMOVE THE STIFFENING CANNULA FROM THE STENT, LEAVING THE WIRE GUIDE IN PLACE.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, IFU AND DEVICE EVALUATION OF THE FLEXIBLE STIFFENER SUGGESTS THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK MEDICAL CONCLUDED THE ROOT CAUSE CATEGORY WOULD FALL UNDER CAUSE TRACED TO COMPONENT FAILURE. IT IS ALSO FEASIBLE TO CONCLUDE THAT USER ERROR CONTRIBUTED TO THE ADVERSE EVENT, BECAUSE THE USER LEFT THE SEPARATED STIFFENER IN THE CATHETER AND THAT LIKELY CONTRIBUTED TO THE DRAINAGE ISSUES. 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

    IT WAS REPORTED THAT THE STIFFENER FROM AN ULTRATHANE COPE NEPHROURETEROSTOMY SET SEPARATED. THE DEVICE WAS PLACED IN THE PATIENT'S KIDNEY AND BLADDER ON (B)(6) 2023. NO ISSUES WERE NOTED DURING THE PROCEDURE. SEVENTEEN DAYS AFTER THE PROCEDURE, THE CATHETER WAS NOT DRAINING, SO THE PATIENT RETURNED TO THE FACILITY. AN ATTEMPT TO ADVANCE A DILATOR THROUGH THE CATHETER WAS UNSUCCESSFUL. IT WAS THEN DISCOVERED THAT A PORTION OF THE STIFFENER WAS RETAINED IN THE CATHETER. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A LIKE DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    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
    1824608 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention