BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 10373742 · Received August 6, 2020

    Report

    Report Number
    1820334-2020-01443
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    August 4, 2020
    Report Date
    October 2, 2020
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002094970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION C. D10 ¿ PRODUCT RECEIVED ON: 01SEP2020. INVESTIGATION ¿ EVALUATION: (B)(6) MEDICAL FROM (B)(6) INFORMED COOK OF AN INCIDENT INVOLVING A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER. ON 04AUG2020 DURING A DRAINAGE PROCEDURE, THE CATHETER MET RESISTANCE UPON ADVANCING. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY, THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, 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 COMPLAINANT RETURNED ONE USED DEVICE TO COOK FOR INVESTIGATION. ONE CATHETER WAS RETURNED WITH BIOMATTER PRESENT. THE BLUE FLEXIBLE STIFFENER WAS FULLY INSERTED INTO THE CATHETER. THE FLEXIBLE STIFFENER COULD BE REMOVED FROM THE CATHETER WITH NO RESISTANCE. THERE WAS NO DAMAGE TO EITHER THE CATHETER OR THE STIFFENER. THE OUTER DIAMETER OF THE CATHETER WAS MEASURED WITHIN SPECIFICATION. THE CUSTOMER ALSO PROVIDED A PHOTO OF THE COMPLAINT DEVICE. FROM THE IMAGE, THERE IS BIOMATTER ON THE CATHETER. THE STIFFENER IS FULLY INSERTED INTO THE CATHETER. THERE IS NO DAMAGE TO THE SURFACE OF THE CATHETER. ADDITIONALLY, 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. ALL TESTED DEVICES MET THE ACCEPTANCE CRITERION FOR CATHETER¿S LUBRICITY AND MECHANICAL ABRASION. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: -¿ACTIVATE THE HYDROPHILIC COATING, IF PRESENT, BY WETTING THE CATHETER WITH STERILE WATER OR SALINE. FOR BEST RESULTS, KEEP CATHETER SURFACE WET DURING PLACEMENT.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS RECORDS NO RELATED NONCONFORMANCES. A DATABASE SEARCH WAS COMPLETED ON THE COMPLAINT LOT AND NO ADDITIONAL COMPLAINTS WERE FOUND. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO RELATED NON-CONFORMANCES AND NO ADDITIONAL COMPLAINTS FROM THE SAME LOT, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. FINDINGS OF THIS INVESTIGATION REVEALED NO EVIDENCE TO SUGGEST THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. IT IS POSSIBLE THE HYDROPHILIC COATING WAS NOT ACTIVATED WHICH CAN CAUSE DIFFICULTY ADVANCING THE CATHETER INTO THE PATIENT. IN ADDITION, IF THE PATIENT¿S ANATOMY IS TORTUOUS THIS CAN ALSO CAUSE DIFFICULT ADVANCEMENT. HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, THE CONCLUSION FOR THIS COMPLAINT IS CAUSE TRACED TO A COMPONENT FAILURE WITHOUT A MANUFACTURING OR DESIGN DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING 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

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: LJE, GBO. OCCUPATION: UNKNOWN. 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 A (B)(6) YEAR OLD FEMALE PATIENT REQUIRED AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FOR DRAINAGE. DURING ADVANCEMENT OF THE CATHETER INTO THE PATIENT, THE OPERATOR REPORTED RESISTANCE. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE TO COMPLETE THE PROCEDURE. 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
    838857 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A 9926126 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR