BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER

    MDR report key: 7965851 · Received October 15, 2018

    Report

    Report Number
    1820334-2018-03073
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 27, 2018
    Report Date
    December 12, 2018
    Manufacturer
    COOK INC
    Product Code
    GCA
    UDI-DI
    00827002094970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND SPECIFICATIONS OF THE DEVICE WAS 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. BASED ON THE REVIEW OF CURRENT DOCUMENTATION, INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THE RISK SPECIFICATIONS COVERING MAC-LOC DRAINAGE CATHETERS INCLUDE BOTH HUB SEPARATION AND LEAKAGE AS A POTENTIAL FAILURE MODE. THE IDENTIFIED RISK CONTROLS INCLUDE THE MANUFACTURING QUALITY CONTROL CHECKS AND PROCESS VALIDATION. THE TECHNICAL FILES COVERING MAC-LOC CATHETERS INDICATE THAT THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE INSTRUCTIONS FOR USE (IFU) ADVISE THE USER TO INSPECT THE PRODUCT PRIOR TO USE TO ENSURE THAT NO DAMAGE HAS OCCURRED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR LOT 8896703 AND REVEALED TWO NONCONFORMANCES FOR A FITTING THAT WAS NOT PROPERLY SECURED AND A CURVE WHICH DID NOT CORRESPOND WITH THE TEMPLATE, ALL OF WHICH WERE SCRAPPED. ONE NONCONFORMANCE WAS FOUND IN MAC-LOC SUBASSEMBLY LOT SA748970 FOR AN EXTRA HOLE IN FLASH, WHICH WAS SCRAPPED. FOUR ADDITIONAL, UNRELATED NONCONFORMANCES WERE FOUND IN TUBING SUBASSEMBLY LOT SA8765744 FOR FOREIGN MATTER, ROUGH COATING, FOREIGN MATTER AND A BAD PATTERN, OF WHICH ALL WERE SCRAPPED. THREE NONCONFORMANCES WERE FOUND IN TUBING SUBASSEMBLY LOT SA8765742 FOR DAMAGE, FOREIGN MATTER AND IRREGULAR COATING OF WHICH ALL WERE SCRAPPED. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED FOR LOT 8896703. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING 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

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    OCCUPATION: UNKNOWN. PMA/510(K) #: PRE-AMENDMENT. 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 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS PLACED IN THE PATIENT FOR A BILIARY DRAINAGE PROCEDURE. UPON PLACEMENT, LEAKAGE WAS DISCOVERED AT THE CONNECTION BETWEEN THE CATHETER AND THE HUB. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION INCLUDING PATIENT INFORMATION HAS BEEN REQUESTED. HOWEVER, NONE HAS BEEN RECEIVED. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED OF AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806717 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY GCA COOK INC N/A 8896703 00827002094970

    Patients

    Seq Age Sex Outcome Treatment
    1