BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 10643720 · Received October 7, 2020

    Report

    Report Number
    1820334-2020-01815
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    October 2, 2020
    Report Date
    December 23, 2020
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002481640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. D10 ¿ PRODUCT RECEIVED ON: 22OCT2020 INVESTIGATION ¿ EVALUATION LBJ GENERAL HOSPITAL IN THE UNITED STATES INFORMED COOK THAT ON 02OCT2020, A USER HAD DIFFICULTY WITHDRAWING THE FLEXIBLE STIFFENER FROM AN ULTRATHANE COPE NEPHROURETEROSTOMY SET DRAINAGE CATHETER. THE USER PLACED THE DEVICE FOR DRAINAGE AND WHEN THEY TRIED TO REMOVE THE STIFFENER, IT BEGAN TO STRETCH AND WOULD NOT WITHDRAW. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES AND DID NOT EXPERIENCE ADVERSE EFFECTS. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. THE CUSTOMER RETURNED ONE USED DEVICE. THE CATHETER HAS BIOLOGICAL MATTER THROUGHOUT AND THE FLEXIBLE STIFFENER IS PARTIALLY INSERTED. THE STIFFENER HAS A 13.5CM KINKED AND ELONGATED SECTION STARTING AT 5MM FROM THE PROXIMAL FITTING. THE FLEXIBLE STIFFENER WAS ABLE TO BE REMOVED FROM THE CATHETER WITH DIFFICULTY. THE CATHETER WAS CUT TO OBTAIN THE INNER DIAMETER. THE OUTER DIAMETER OF THE FLEXIBLE STIFFENER WAS NOT MEASURED DUE TO DAMAGE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THE CATHETERS ARE 100% VERIFIED FOR AN OPEN LUMEN. COOK DID NOT IDENTIFY GAPS IN THE QUALITY CONTROL PROCESS. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION TO CHECK FOR FAILURE RELATED NONCONFORMANCES AND ADDITIONAL COMPLAINTS. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS DID NOT HAVE FAILURE-RELATED NONCONFORMANCES. A REVIEW OF THE COMPLAINT HISTORY FOR THE SHOWS ONE ADDITIONAL COMPLAINT (REPORTED UNDER MEDWATCH REPORT#:1820334-2020-01861). THE COMPLAINT IS FROM THE SAME USER FACILITY AND REPORT THE SAME FAILURE OF DIFFICULT REMOVAL OF THE FLEXIBLE STIFFENER FROM THE CATHETER. THE CUSTOMER RETURNED ONE USED AND 4 UNUSED DEVICES UNDER THE ADDITIONAL COMPLAINT. ANALYSIS SHOWED THAT THE USED CATHETER INNER DIAMETER MEASURED WITHIN SPECIFICATION. THE STIFFENER DIAMETER COULD NOT BE MEASURED DUE TO DAMAGE. COOK WAS UNABLE TO DUPLICATE THE REPORTED DIFFICULTY WITH THE FOUR UNUSED DEVICES, AS THE STIFFENERS WERE ADVANCED AND REMOVED WITHOUT ISSUE. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL FROM THIS LOT IN HOUSE OR IN THE FIELD. THE DEVICE EVALUATION CONFIRMED THAT THE CATHETER WAS MANUFACTURED WITHIN SPECIFICATION. IT IS POSSIBLE THAT THE ANGLE OF THE PATIENT'S ANATOMY CAUSED RESISTANCE DURING STIFFENER REMOVAL, BUT THIS WAS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, THE CAUSE FOR THIS EVENT IS COMPONENT FAILURE WITHOUT DESIGN OR MANUFACTURING ISSUE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

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

    Additional Manufacturer Narrative · 1

    OCCUPATION: IR SUPERVISOR. 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.

    Description of Event or Problem · 1

    AS REPORTED, AN UNKNOWN PATIENT REQUIRED THE USE OF A ULTRATHANE COPE NEPHROURETERECTOMY SET FOR AN UNKNOWN PROCEDURE. THE OPERATOR REPORTED THAT UPON REMOVING THE STIFFENING CANNULA FROM THE CATHETER IT WAS NOTED TO BE STRETCHED WHERE THE BLUE AND YELLOW PART COME TOGETHER ON THE DEVICE. NO OTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108056 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A 10279176X 00827002481640

    Patients

    Seq Age Sex Outcome Treatment
    1