BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 10134526 · Received June 9, 2020

    Report

    Report Number
    1820334-2020-01094
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Report Date
    July 10, 2020
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002094970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL METHODS CODE: DEVICE NOT RETURNED (4114). INVESTIGATION ¿ EVALUATION : IT WAS REPORTED THAT THE FLEXIBLE STIFFENER WITHIN A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER, COULD NOT BE REMOVED FROM THE CATHETER. THIS INCIDENT WAS REPORTED BY HOSPITAL (B)(6) , IN SPAIN. THE DEVICE WAS REMOVED, AND ANOTHER WAS PLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS WERE REPORTED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE 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. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. PRODUCT LABELING WAS ALSO REVIEWED. INSTRUCTIONS FOR USE ARE PACKAGED WITH THIS DEVICE. RELEVANT SECTIONS INCLUDE: 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 UPSET HE 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.¿ IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD (DHR). THE REPORTED LOT CONSISTS OF ONE TUBING SUBASSEMBLY AND ONE FLEXIBLE STIFFENER RAW MATERIAL. THE DHR FOR THE ABOVE LOTS RECORDS NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND FIVE TOTAL COMPLAINTS FROM THE FIELD. DUE TO ADDITIONAL RELEVANT COMPLAINTS REPORTED ON THE SAME LOT, FURTHER INVESTIGATION WAS NECESSARY. THE REPORTED TUBING SUBASSEMBLY WAS USED IN THREE ADDITIONAL FINAL LOTS. THE DHRS FOR THESE LOTS WERE REVIEWED AND FOUND NO RELEVANT NONCONFORMANCES. A DATABASE SEARCH FOR COMPLAINTS ON THESE LOTS FOUND NO COMPLAINTS REPORTED FROM THE FIELD. THE REPORTED COMPLAINT DEVICE WAS NOT RETURNED, AND NO ADDITIONAL DEVICES FROM ANY OF THE POSSIBLE LOTS REMAIN IN HOUSE FOR FURTHER TESTING. FROM THIS INFORMATION, COOK CANNOT CONCLUDE THAT NONCONFORMING PRODUCT FROM THE REPORTED LOT OR ADDITIONAL LOTS EXISTS IN HOUSE OR IN THE FIELD. A CAPA IS CURRENTLY OPEN TO INVESTIGATE THIS ISSUE. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: SOMETIME OVER THE LAST 3 WEEKS PRIOR TO (B)(6) 2020. COMMON DEVICE NAME: 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.

    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. THE FLEXIBLE STIFFENING CANNULA WAS LOADED INTO THE CATHETER IN ORDER TO STRAIGHTEN THE PIGTAIL. HOWEVER, UPON ATTEMPTING TO REMOVE THE STIFFENER, IT WAS "IMPOSSIBLE" TO RETRIEVE. THE OPERATOR REPORTED THE CANNULA AND CATHETER SEEMED TO BE ADHERED. WHEN TRYING TO REMOVE THE STIFFENER WITH MORE FORCE, THE CATHETER TIP "WRINKLED." THE ENTIRE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599645 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 10144644 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1