BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 14886897 · Received July 1, 2022

    Report

    Report Number
    1820334-2022-01146
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Report Date
    January 6, 2023
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002481763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION: LAB MANAGER. 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. CORRECTION: D9, H3 INVESTIGATION ¿ EVALUATION. ON 13JUN2022, COOK MEDICAL RECEIVED A COMPLAINT FROM A REPRESENTATIVE AT THE (B)(6) MEDICAL CENTER LOCATED IN THE CITY OF (B)(6) . UPON THE REPLACEMENT OF A PREVIOUS ULTRATHANE COPE NEPHROURETEROSTOMY CATHETER WITH A NEW ULTRATHANE COPE NEPHROURETEROSTOMY SET (RPN: ULT8.5-8.5-24-NUCL-B-RH, LOT: 13968635) OVER A WIRE GUIDE, THE HUB TO THE SUPPLIED FLEXIBLE STIFFENER SEPARATED UPON REMOVAL FROM THE CATHETER. THE STIFFENER WAS OUTSIDE THE PATIENT, AND THE CATHETER WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, 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, NO PHYSICAL EXAMINATIONS COULD BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT THE SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 13968635, CATHETER SUBASSEMBLY LOTS (SA13816202 AND SA13816205), RADIOPAQUE BAND TUBING LOTS (SA13816239 AND SA13878953) AND RAW MATERIAL LOTS FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. NONCONFORMANCES RELEVANT TO THE FAILURE WERE FOUND FOR SUBASSEMBLY LOT SA13816239 FOR ¿SHAFT DIFFICULT TO WIRE" (QTY 5) AND SA13878953 FOR ¿TIGHT ID¿ (QTY 1 ), IN WHICH ALL NONCONFORMING DEVICES WERE SCRAPPED PRIOR TO FURTHER PROCESSING. IT SHOULD BE NOTED THAT THERE WAS ONE OTHER COMPLAINT ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER REGARDING SUTURE BREAKAGE. COOK ALSO REVIEWED PRODUCT LABELING. PER THE IFU, T_NUCL_REV4, 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. EVIDENCE PROVIDED UPON REVIEW OF THE DMR, IFU AND DHR 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 A COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT. IT IS FEASIBLE TO SUGGEST THAT THE SUTURE STRING BECAME TANGLED AROUND THE STIFFENER DUE TO THE STRING BEING IMPROPERLY HELD. AS THE COMPLAINT DEVICE WAS NOT RETURNED, THIS CANNOT BE CONFIRMED. 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 A PATIENT REQUIRED A ULTRATHANE COPE NEPHROURETERECTOMY SET FOR A BILATERAL DRAIN EXCHANGE IN THE KIDNEYS. DURING THE PROCEDURE, THE STIFFENER'S HUB SEPARATED UPON REMOVAL. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE OF THE SAME LOT, AND THE SUTURE BROKE UPON LOCKING THE PIGTAIL. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED BY PLACING TWO SIMILAR DEVICES FOR BILATERAL DRAINAGE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    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
    2279724 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC N/A 13968635 00827002481763

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown