BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 11953620 · Received June 7, 2021

    Report

    Report Number
    1820334-2021-01472
    Event Type
    Injury
    Date Received
    June 7, 2021
    Report Date
    April 19, 2022
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002481640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION . ON (B)(6) 2021, AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF AN ULT10.2-10.2-24-NUCL-B-RH, ULTRATHANE COPE NEPHROURETEROSTOMY, LOT NUMBER 13773286. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO THE HUB SEPARATING FROM THE TUBING. THE ULTRATHANE COPE NEPHROURETEROSTOMY CATHETER WAS REMOVED AND ANOTHER SIMILAR DEVICE WAS PLACED TO CONTINUE TREATMENT. NO OTHER ADVERSE EFFECTS WERE REPORTED IN THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, 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. THE RISK SPECIFICATIONS COVERING MAC-LOC DRAINAGE CATHETERS INCLUDES HUB SEPARATION AS A POTENTIAL FAILURE MODE. THE IDENTIFIED RISK CONTROLS INCLUDE THE MANUFACTURING QUALITY CONTROL CHECKS AND PROCESS VALIDATION. THE TECHNICAL FILES COVERING MAC-LOC DRAINAGE CATHETERS INDICATE THAT THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. BASED ON THE REVIEW OF CURRENT DOCUMENTATION, COOK HAS CONCLUDED THAT INSPECTION ACTIVITIES ARE IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. THE IFU SUPPLIED WITH THE MAC-LOC DRAINAGE CATHETERS INSTRUCT THAT THE PRODUCT SHOULD BE INSPECTED PRIOR TO USE TO ENSURE NO DAMAGE HAS OCCURRED. A REVIEW OF ALL ASSOCIATED DEVICE HISTORY RECORDS CONFIRMED NO RELATED NON-CONFORMANCES. TO DATE, A FURTHER SEARCH OF OUR DATABASE RECORDS REVEALED THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED WITH THE COMPLAINT LOT NUMBER. SINCE THERE IS OBJECTIVE EVIDENCE THE DHR WAS FULLY EXECUTED, AND THERE ARE NO OTHER LOT-RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO CURRENT SPECIFICATION. THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT DEVICE NOT BEING RETURNED, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE WAS TRACED TO A COMPONENT FAILURE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE 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

    OCCUPATION: INITIAL REPORTER OCCUPATION: INVENTORY MANAGER. PMA/510(K)#: K171603. 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 THAT AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET. THE DEVICE WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR DEVICE HUB SEPARATION. THE DEVICE WAS REMOVED AND REPLACED WITH A LIKE DEVICE WITHOUT INCIDENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841508 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC G48164 13773286 00827002481640

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention