BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 14916149 · Received July 5, 2022

    Report

    Report Number
    1820334-2022-01156
    Event Type
    Injury
    Date Received
    July 5, 2022
    Date of Event
    April 16, 2021
    Report Date
    December 19, 2022
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002094970
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PROCODE: ADDITIONAL CODE: LJE,GBO. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION. ON 22JUN2022, COOK RESEARCH INC. RECEIVED A COMPLAINT FROM THE (B)(6) UNIVERSITY MEDICAL CENTER, LOCATED IN THE CITY OF DALLAS, TX REPORTING THE FOLLOWING: TWO DAYS POST PROCEDURE THE ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER (RPN:ULT8.5-38-40-P-32S-CLB-RH; LOT NUMBER: 13580167) HAD RETRACTED RESULTING IN LEAKAGE AT THE SITE. THE PATIENT PRESENTED WITH A BILE OBSTRUCTION. ON (B)(6) 2021 THE PATIENT UNDERWENT A STUDY PROCEDURE (MDR-1919) FOR A BILIARY ANASTOMOTIC STRICTURE AFTER A LIVER TRANSPLANT TO PLACE A CATHETER FOR BILIARY DRAINAGE. A COOK ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS PLACED USING ULTRASOUND AND FLUOROSCOPY FOR VISUAL GUIDANCE. DILATION WAS PERFORMED PRIOR TO CATHETER PLACEMENT. IT WAS REPORTED THAT WHILE THE CATHETER WAS INDWELLING, THE PATIENT HAD A REDUCTION IN BILIRUBIN LEVELS OR A REDUCTION IN CLINICAL SYMPTOMS OF BILE OBSTRUCTION. ON (B)(6) 2021, TWO DAYS POST-PROCEDURE IT WAS DISCOVERED THAT THE BILIARY DRAINAGE CATHETER HAD RETRACTED AND WAS LEAKING AROUND THE SITE. COMPLETE FLUID EVACUATION WAS NOT ABLE TO BE ACHIEVED USING THIS DEVICE. THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2021. NO ADVERSE EVENTS WERE REPORTED PRIOR TO THE PATIENT'S EXIT FROM THE STUDY. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, 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 DHRS FOR THE REPORTED COMPLAINT DEVICE LOT 13580167 AND THE RELATED SUBASSEMBLY LOTS REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. TO DATE, A SEARCH OF OUR DATABASE RECORDS REVEALED NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE REPORTED LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) DOCUMENT T_MULTI_REV5 [MULTIPURPOSE DRAINAGE CATHETER] IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: PRECAUTIONS: IT IS RECOMMENDED TO USE A WIRE GUIDE WHEN REMOVING A LOCKING LOOP CATHETER. UNLOCKING CATHETER LOOP FOR MAC-LOC LOCKING LOOP MECHANISM: A. WHILE STABILIZING THE MAC-LOC CATHETER HUB ASSEMBLY WITH ONE HAND, POSITION A SMALL, BLUNT OBJECT (APPROXIMATELY THE SHAPE AND SIZE OF A BALL POINT PEN OR SMALL FORCEPS) INTO THE MAC-LOC RELEASE NOTCH. B. PRY UPWARD UNTIL THE LOCKING CAM LEVEL IS FREE. (FIG. 6). NOTE: FOR CATHETER EXCHANGE, ADVANCE THE DISTAL END OF A WIRE GUIDE INTO THE LOCKED LOOP CONFIGURATION OF THE CATHETER BEFORE UNLOCKING THE MAC-LOC ASSEMBLY. RELEASE THE MAC-LOC AS DESCRIBED ABOVE. ADVANCE THE WIRE GUIDE THROUGH THE CATHETER END HOLE. CATHETER EXCHANGE CAN NOW BE PERFORMED.¿ HOW SUPPLIED: 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 AVAILABLE INFORMATION, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. 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 AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER MIGRATED. ON (B)(6) 2021 THE PATIENT UNDERWENT A STUDY PROCEDURE (MDR-1919) TO PLACE A CATHETER FOR BILIARY DRAINAGE. DILATION WAS PERFORMED PRIOR TO CATHETER PLACEMENT, THEN THE DEVICE WAS PLACED VIA ULTRASOUND AND FLUOROSCOPY GUIDANCE. WHILE THE CATHETER WAS INDWELLING, THE PATIENT HAD A REDUCTION IN BILIRUBIN LEVELS OR A REDUCTION IN CLINICAL SYMPTOMS OF BILE OBSTRUCTION. TWO DAYS AFTER PLACEMENT, THE CATHETER RETRACTED AND LEAKED AROUND THE SITE; THEREFORE, THE DEVICE WAS REMOVED AND REPLACED. NO OTHER ADVERSE EVENTS WERE REPORTED PRIOR TO THE PATIENT'S EXIT FROM THE STUDY.

    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
    1619385 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 13580167 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention