BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 17839496 · Received September 28, 2023

    Report

    Report Number
    1820334-2023-01305
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    September 20, 2023
    Report Date
    February 16, 2024
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3 - OCCUPATION: SENIOR CLINICAL VALUE ANALYST 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. ON 21SEP2023, IT WAS REPORTED THAT THE STENT INCLUDED IN THE ULTRATHANE COPE NEPHROURETEROSTOMY SET BROKE UPON PLACEMENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE USER FACILITY AND OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT INSPECTION ACTIVITIES ARE CURRENTLY IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. A SALES SEARCH OF THE RPN TO THE CUSTOMER WAS UNABLE TO IDENTIFY A LOT NUMBER. COOK WAS ALSO ABLE TO REVIEW PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE T_NUCL_REV5 (COPE NEPHROURETEROSTOMY STENTS) PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "PRECAUTIONS: ¿ MANIPULATION OF PRODUCT REQUIRES FLUOROSCOPIC CONTROL. ¿ A PTFE-COATED WIRE GUIDE MUST BE USED WITH THIS PRODUCT. ¿ WHERE LONG-TERM USE IS INDICATED. IS INDICATED, IT IS RECOMMENDED THAT INDWELLING TIME NOT EXCEED 90 DAYS AND THAT THE PHYSICIAN EVALUATE THE CATHETER BEFORE THIS TIME EXPIRES. INSTRUCTIONS FOR USE: FIX THE CATHETER AT THE SKIN SURFACE AND APPLY DRESSINGS. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." EVIDENCE PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT 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, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE INCIDENT. IT IS POSSIBLE THAT THE CATHETER UNDERWENT EXCESSIVE FORCE OR TENSION WHILE PLACED IN THE PATIENT. HOWEVER, THIS CANNOT BE DEFINITIVELY CONFIRMED WITHOUT MORE INFORMATION FROM THE USER FACILITY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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

    IT WAS REPORTED BY INTERVENTIONAL RADIOLOGY (IR) CLINICIANS THAT THE CATHETER OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET "BROKE" FOLLOWING PLACEMENT IN AN UNKNOWN PATIENT. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT, DEVICE AND EVENT DETAILS HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157289 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown