BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 19608207 · Received June 25, 2024

    Report

    Report Number
    1820334-2024-00856
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 1, 2024
    Report Date
    August 8, 2024
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002094970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY D2B - PROCODE: ADDITIONAL PRODUCT CODES: GBO, LJE. G4 ¿ PMA/510(K) #: K173035. 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

    CORRECTION: D4- MODEL# INVESTIGATION ¿ EVALUATION: ON 01MAY2024, IT WAS REPORTED THAT THE SUPPLIED FLEXIBLE STIFFENER FROM ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS DEFECTIVE. NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL PROCEDURES, INSTRUCTIONS FOR USE AND SPECIFICATIONS AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE SUPPLIED FLEXIBLE STIFFENER WAS RETURNED IN A USED AND DAMAGED CONDITION. THE HUB OF THE FLEXIBLE STIFFENER WAS MISSING WITH EVIDENCE OF MATERIAL ELONGATION, AT THE POINT OF SEPARATION. KINKS IN THE MATERIAL WERE PRESENT AT APPROXIMATELY 1.5CM, WITH EVIDENCE OF MATERIAL ELONGATION, HAVING A LENGTH MEASUREMENT OF APPROXIMATELY 1MM, AND A SECOND KINK IN THE MATERIAL WAS PRESENT AT 9.0CM, MEASURING FORM THE PROXIMAL END. THE SUPPLIED ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS NOT RETURNED FOR OUR EVALUATION. DIMENSIONAL ANALYSIS CONFIRMED THAT THE FLEXIBLE STIFFENER WAS MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. 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 DEVICE HISTORY RECORD (DHR) FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RELEVANT NON-CONFORMANCES 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: THE PRODUCT IFU, [T_MULTI2_REV1] ¿MULTIPURPOSE DRAINAGE CATHETER,¿ THE FOLLOWING INSTRUCTIONS APPLIES TO THE REPORTED DIFFICULTY: "PRECAUTIONS: WHEN INSERTING A STIFFENING CANNULA INTO A CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF SUTURE. HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ EVIDENCE GATHERED UPON REVIEW OF DMR, DHR, IFU AND DEVICE EVALUATION, SUGGESTS THAT THE DEVICE WAS NOT OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO DESIGN OR MANUFACTURING DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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

    IT WAS REPORTED THAT THE FLEXIBLE STIFFENER FROM AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS DEFECTIVE, SO ANOTHER DEVICE WAS OPENED. 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. UPON RECEIPT OF THE COMPLAINT DEVICE, IT WAS DISCOVERED THE FLEXIBLE STIFFENER WAS ELONGATED, AND THE HUB WAS SEPARATED, THUS PROMPTING THIS REPORT. THE HUB WAS NOT RETURNED.

    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
    2101645 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC G09497 14942191 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown