BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 16765550 · Received April 18, 2023

    Report

    Report Number
    1820334-2023-00462
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    April 13, 2023
    Report Date
    September 19, 2023
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002481640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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): STREET: (B)(6). 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: ON 14APR2023, COOK MEDICAL INC. RECEIVED A COMPLAINT FROM THE (B)(6) HOSPITAL, LOCATED IN THE CITY OF (B)(6). UPON THE PLACEMENT OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET (RPN: ULT10.2-10.2-24-NUCL-B-RH, LOT: 15217784), THE HUB TO THE BLUE STIFFENER BROKE WHEN ATTEMPTING TO REMOVE FROM THE CATHETER. THE SHAFT OF THE BLUE STIFFENER WAS ALL IN ONE PIECE. ADDITIONALLY, THE BLACK SUTURE STRING ALSO BROKE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTION FOR USE (IFU), QUALITY CONTROL PROCEDURES AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED FOR EVALUATION IN A USED AND DAMAGED CONDITION. THE FLEXIBLE STIFFENER WAS RETURNED WITH THE PROXIMAL HUB SEPARATED FROM THE SHAFT. MATERIAL ELONGATION WAS NOTED NEAR THE PROXIMAL END OF THE STIFFENER. THE SUTURE STRING WAS FOUND TO BE BROKEN. THE STRING WAS PRESENT WITHIN THE SPECIFIED LOOP BUT WAS MISSING FROM THE LOCK LEVER OF THE MAC-LOC ADAPTOR. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 15217784 AND RELATED SUBASSEMBLY LOTS FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK ALSO REVIEWED PRODUCT LABELING. PER THE ATTACHED IFU, T_NUCL_REV5, IN RELATION TO THE REPORTED FAILURE MODE UNDER THE HEADING INSTRUCTIONS FOR USE READS: ¿AFTER ESTABLISHING PROPER PROXIMAL AND DISTAL POSITION, PUSH THE STENT OFF THE STIFFENING CANNULA OVER THE WIRE, MAKING SURE THE DISTAL PIGTAIL FORMS WITHIN THE BLADDER. REMOVE THE STIFFENER CANNULA FROM THE STENT, LEAVING THE WIRE GUIDE IN PLACE.¿ EVIDENCE PROVIDED BY THE COMPLAINT FACILITY, DEVICE FAILURE ANALYSIS, DHR, COMPLAINT HISTORY, AND MANUFACTURING DOCUMENTS SUGGESTS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT COMPONENT FAILURE WITHOUT DESIGN OR MANUFACTURING DEFICIENCY LIKELY CONTRIBUTED TO THE EVENT. IT IS POSSIBLE THAT THE BLUE FLEXIBLE STIFFENER UNDERWENT EXCESSIVE FORCE OR TENSION WHILE BEING REMOVED FROM THE PATIENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLUE FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE DURING THE PLACEMENT OF A NEPHROURETEROSTOMY STENT IN THE KIDNEY OF AN UNKNOWN PATIENT. DUE TO THE DIFFICULT REMOVAL, THE BLUE FLEXIBLE STIFFENER AND SUTURE STRING BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW LIKE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED ON 28APR2023 AND PRELIMINARY DEVICE FAILURE ANALYSIS OF THE RETURNED COMPLAINT DEVICE ON 03MAY2023 CONFIRMED THE HUB SEPARATED FROM THE BLUE FLEXIBLE STIFFENER WHEN BEING REMOVED. ALSO, NO OTHER PART OF THE BLUE FLEXIBLE STIFFENER WAS NOTED TO BE SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541270 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A 15217784 00827002481640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown