BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 12606787 · Received October 11, 2021

    Report

    Report Number
    1820334-2021-02310
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    March 19, 2021
    Report Date
    October 11, 2021
    Manufacturer
    COOK INC
    Product Code
    GBO
    UDI-DI
    00827002094970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODES: FGE, LJE. INITIAL REPORTER OCCUPATION: INVENTORY. PMA/510(K) #: K173035. INVESTIGATION ¿ EVALUATION: COOK MEDICAL INC. RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL- (B)(6) STATING THAT THE FLEXIBLE STIFFENER IN A ULT8.5-38-40-P-32S-CLB-RH [ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER, LOT 13638204] WOULD NOT ADVANCE INTO THE DRAINAGE CATHETER. THEY NOTED THAT THE DEVICE WAS DAMAGED UPON OPENING THE PACKAGE, AND WHEN THE USER TRIED TO INSERT THE STIFFENER INTO THE CATHETER, IT WOULD NOT ADVANCE SMOOTHLY. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. THE CATHETER WAS RETURNED IN AN OPENED, PREPPED BUT DAMAGED CONDITION. THE INVESTIGATION DISCOVERED A PORTION OF THE FLEXIBLE STIFFENER SEPARATED AND LODGED WITHIN THE DRAINAGE CATHETER. ADDITIONALLY, THE INVESTIGATION CONFIRMED THE SUPPLIED BLUE FLEXIBLE STIFFENER AND THE DRAINAGE CATHETER WERE WITHIN SPECIFICATION. A REVIEW OF ALL ASSOCIATED DEVICE HISTORY RECORDS CONCLUDED THERE WERE NO RELEVANT RECORDED NON-CONFORMANCES. TO DATE, A FURTHER SEARCH OF OUR DATABASE RECORDS REVEALED THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED WITH THE COMPLAINT LOT NUMBER. SINCE THERE IS OBJECTIVE EVIDENCE THE DHR WAS FULLY EXECUTED, AND THERE ARE NO OTHER LOT-RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD AND THAT THE DEVICE WAS MANUFACTURED TO CURRENT SPECIFICATION. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_MULTI_REV5] ¿MULTIPURPOSE DRAINAGE CATHETER,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: ¿WHEN INSERTING A STIFFENING CANNULA INTO A CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF SUTURE.¿ INSTRUCTIONS FOR USE: ¿UNDER FLUOROSCOPIC CONTROL, PERFORM STANDARD TECHNIQUES FOR PLACEMENT OF PERCUTANEOUS DRAINING CATHETERS, EITHER BY SELDINGER ACCESS OR TROCAR ACCESS. -ONCE CATHETER IS IN DESIRED LOCATION, REMOVE ANY WIRE GUIDES, TROCARS, OR STIFFENERS, ALLOWING THE CATHETER TO FOR ITS CONFIGURATION.¿ 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.¿ BASED ON THE INFORMATION PROVIDED, INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT THE CAUSE OF THIS EVENT IS COMPONENT FAILURE WITHOUT DESIGN OR MANUFACTURING DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FOR A BILIARY DRAINAGE PROCEDURE. PRIOR TO PATIENT CONTACT, IT WAS NOTED THE STIFFENER WAS DAMAGED. THE PHYSICIAN ATTEMPTED TO LOAD THE STIFFENER INTO THE DRAINAGE CATHETER BUT IT WOULD NOT ADVANCE SMOOTHLY. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. UPON RETURN OF THE DEVICE ON 19MAY2021, IT WAS NOTED THAT THE FLEXIBLE STIFFENER SEPARATED WITHIN THE CATHETER SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501493 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 13638204 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1