BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 7948794 · Received October 9, 2018

    Report

    Report Number
    1820334-2018-03010
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Report Date
    January 8, 2019
    Manufacturer
    COOK INC
    Product Code
    LJE
    UDI-DI
    00827002481800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AS WELL AS A FUNCTIONAL TEST, VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE PARTIAL, LOCKED 8.5FR CATHETER WAS RETURNED FOR EVALUATION IN DAMAGED CONDITION. THE DEVICE WAS COMPRISED OF THE MAC-LOC HUB, CONNECTOR CAP AND APPROXIMATELY 4.5CM OF TUBING ENDING WITH A SEPARATION. IT APPEARS THAT THE SEPARATION IS A CUT. BIOLOGICAL MATTER WAS PRESENT ON THE DEVICE AND HEMOSTAT MARKS WERE FOUND ON THE CONNECTOR CAP. NO ADDITIONAL SURFACE DAMAGE WAS NOTED. A LEAK TEST WAS CONDUCTED AND CONFIRMED THE PRESENCE OF A LEAK BETWEEN THE CATHETER TUBING AND CONNECTOR CAP. TUG AND TWIST TESTS REVEALED THAT THE PROXIMAL ASSEMBLY WAS SECURE, HOWEVER THE TUBING WAS FREELY ABLE TO ROTATE WITHIN THE CAP. UPON REMOVAL OF THE CONNECTOR CAP, THE SUTURE STRING WAS FOUND SLIGHTLY WOUND IN THE THREADS. THE FLARE APPEARED LOPSIDED, BUT DUE TO THE COMPRESSION OF THE FLARE AND THE POTENTIAL FOR DAMAGE UPON REMOVAL, IT CANNOT BE DETERMINED IF THE FLARE WAS MANUFACTURED TO SPECIFICATIONS. DIMENSIONAL ANALYSIS CONFIRMED THAT THE DEVICE AND COMPONENTS WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. UPON VISUAL INSPECTION, HOWEVER, THE NUMBER OF THREADS VISIBLE ON THE CAP EXCEEDED WHAT WAS DETAILED IN MANUFACTURING SPECIFICATIONS. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED FOR LOT 8935221. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. THE CATHETERS WERE MANUFACTURED WITH TOO MANY THREADS SHOWING BETWEEN THE MAC-LOC HUB AND THE CONNECTOR CAP WHICH COULD POTENTIALLY CONTRIBUTE TO THE FAILURE MODE, BUT THIS HAS NOT BEEN CONFIRMED. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. 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 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 THE CATHETER AND HUB OF AN ULTRATHANE COPE NEPHROURETERECTOMY STENT WERE FOUND TO BE SEPARATED UPON OPENING THE PACKAGE. THE DEVICE DID NOT MAKE PATIENT CONTACT. ALTHOUGH REQUESTED, THE DATE OF EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789482 ULTRATHANE COPE NEPHROURETEROSTOMY SET LJE CATHETER, NEPHROSTOMY LJE COOK INC N/A 8935221 00827002481800

    Patients

    Seq Age Sex Outcome Treatment
    1