BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 19005811 · Received March 29, 2024

    Report

    Report Number
    1820334-2024-00442
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    March 13, 2024
    Report Date
    July 17, 2024
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002481701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1- CUSTOMER (PERSON): POSTAL CODE = (B)(6). E3- OCCUPATION: OPERATING ROOM CLINICAL PURCHASING SECRETARY 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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE STIFFENER OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS DIFFICULT TO REMOVE FROM THE DRAINAGE CATHETER. ADDITIONALLY, THE STRING THAT FORMS THE PROXIMAL PIGTAIL BECAME DETACHED WHEN PULLED. NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION, DIMENSIONAL VERIFICATION, AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. A TOTAL OF TWO BLUE FLEXIBLE STIFFENERS ALONG WITH ONE ULTRATHANE COPE NEPHROURETEROSTOMY CATHETER WERE RETURNED IN A USED AND DAMAGED CONDITION. BOTH STIFFENERS WERE RECEIVED LOOSE WITHIN THE RETURNED PACKAGE. DURING THE INVESTIGATION, ONE OF THE TWO STIFFENERS EXHIBITED SHAFT DAMAGE AND WOULD NOT ADVANCE FULLY ADVANCE INTO THE CATHETER. THE SECOND STIFFENER WOULD NOT FULLY ADVANCE INTO THE CATHETER, WITH NO VISUAL DAMAGE TO THE STIFFENER. THE CATHETER I.D. AND THE O.D. OF THE STIFFENERS WERE CONFIRMED TO BE WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT DISCOVERED ONE NONCONFORMANCE CONFIRMED TO BE RELEVANT TO THE REPORTED DIFFICULTY. THESE DEVICES WERE SCRAPPED PRIOR TO FURTHER PROCESSING. THERE WERE NO RECORDED NONCONFORMANCES FOR ALL OF THE RELATED SUBASSEMBLY LOTS. TO DATE, A FURTHER SEARCH OF THE DATABASE RECORDS REVEALED ONE ADDITIONAL COMPLAINT ASSOCIATED WITH THIS LOT REGARDING A SIMILAR FAILURE. THE COMPLAINT WAS ALSO REPORTED FROM THE SAME FACILITY AS THIS COMPLAINT. COOK ALSO REVIEWED PRODUCT LABELING. THE ATTACHED IFU, T_NUCL_REV5, STATES UNDER THE HEADING "PRECAUTIONS": "WHEN INSERTING A STIFFENING CANNULA INTO THE CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF THE SUTURE." THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND DEVICE EVALUATION 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, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. 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 OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS DIFFICULT TO REMOVE FROM THE DRAINAGE CATHETER. ADDITIONALLY, THE STRING THAT FORMS THE PROXIMAL PIGTAIL BECAME ATTACHED WHEN PULLED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    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
    2592972 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A 15485953 00827002481701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown