BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 8464475 · Received March 29, 2019

    Report

    Report Number
    1820334-2019-00784
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 11, 2019
    Report Date
    May 3, 2019
    Manufacturer
    COOK INC
    Product Code
    LJE
    UDI-DI
    00827002481732
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. NO IMAGES OR VIDEOS WERE PROVIDED. HOWEVER, THE DEVICE IN A SIMILAR COMPLAINT FOR A SIMILAR FAILURE MODE WAS RETURNED UNDER COMPLAINT (B)(4) (MEDWATCH REPORT #1820334-2018-00058). PHYSICAL INSPECTION OF THE DEVICE UNDER (B)(4) DEMONSTRATED THAT THE DEVICE WAS OCCLUDED WITH WHAT APPEARED TO BE BIOMATTER. THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED WITHIN THE CORRECT SPECIFICATIONS. THE INVESTIGATION CONCLUDED THAT THE FAILURE MODE WAS LIKELY RELATED TO PRODUCT USE OR HANDLING. DUE TO THE SIMILARITIES BETWEEN THE TWO CASES, IT IS POSSIBLE THAT THE TWO CASES HAD SIMILAR FAILURE MODES. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED FOR LOT 9212505 RECORDED TWO NONCONFORMANCES. TWO DEVICES WERE SCRAPPED OUT FOR FRAYING OF THE SUTURE AND ONE DEVICE WAS SCRAPPED OUT FOR LOOPS NOT ON THE SAME PLANE. COOK HAS DETERMINED THAT THESE NONCONFORMANCES ARE NOT RELATED TO THE REPORTED FAILURE MODE. NO NONCONFORMANCES WERE REPORTED FOR THE CATHETER SHAFT SUBASSEMBLY LOT. A SOFTWARE SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE COMPLAINT DEVICE LOT. AS THERE ARE NO RELATED NONCONFORMANCES, EVIDENCE THAT THE DHR HAS BEEN FULLY CONDUCTED, ADEQUATE INSPECTION ACTIVITIES ARE IN PLACE, AND NO ADDITIONAL COMPLAINTS WERE REPORTED FOR THE SAME LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR OUT IN THE FIELD. THE DOCUMENT ENSURES THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. 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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    CONCOMITANT MEDICAL PRODUCTS: AMPLANTZ WIRE AND GLIDEWIRE OCCUPATION: UNKNOWN. PMA/510(K) #: PRE-AMENDMENT. (B)(4). 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 ULTRATHANE COPE NEPHROURETERECTOMY SET WAS USED IN AN UNKNOWN PATIENT FOR A ROUTINE REPLACEMENT. AS REPORTED, THE CATHETER WAS IN PLACE FOR APPROXIMATELY 3.5 MONTHS. RADIOLOGIST REPORTS THE WIRE WAS UNABLE TO PASS THROUGH THE STENT. ADDITIONALLY, THE STENT WAS LODGED IN THE PATIENT¿S URETER AND USER WAS UNABLE TO REMOVE THE DEVICE. THE REPORT STATES THE RADIOLOGIST ATTEMPTED TO USE 2 DIFFERENT WIRES, (AMPLANTZ AND GLIDEWIRE) UNSUCCESSFULLY. AN ADDITIONAL PROCEDURE TO REMOVE AND REPLACE WAS PERFORMED BY A UROLOGIST SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258702 ULTRATHANE COPE NEPHROURETEROSTOMY SET LJE CATHETER, NEPHROSTOMY LJE COOK INC N/A 9212505 00827002481732

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention