BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 4808046 · Received May 29, 2015

    Report

    Report Number
    3001845648-2015-00117
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 24, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PARTICULAR RMS-060028 DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED A "SIMILAR DEVICE" TO OTHER URINARY TRACT STENTS/SETS (METALLIC) DEVICES CURRENTLY REGISTERED FOR SALE IN THE US. THE 510(K)# FOR THESE URINARY TRACT STENTS/SETS (METALLIC) DEVICES IS AS FOLLOWS: K063742. INCIDENT MEETS REPORTING CRITERIA OF AN FDA MDR REPORT AS THE REMOVAL OF THE RMS STENTS (AND NEPHROSTOMY DRAINAGE) IS VIEWED AS SURGICAL INTERVENTION TO PREVENT A SERIOUS INJURY AS THE PATIENT HAD DEVELOPED HYDROENPHROSIS. NO DEVICE MALFUNCTION HAS BEEN REPORTED, BUT THE DEVICE NOT DRAINING IS INTERPRETED AS A PERFORMANCE RELATED ISSUE. THE COMPLAINT DEVICE REPORTED WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT NUMBER C1021946 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMER TESTIMONY. A POSSIBLE CAUSE OF THIS COMPLAINT MAY BE ATTRIBUTED TO PATIENT ANATOMY AND PROGRESSION OF DISEASE. RESONANCE STENT DEVICES ARE USED FOR TEMPORARY STENTING OF THE URETER IN ADULT PATIENTS WITH EXTRINSIC URETERAL OBSTRUCTION. THESE DEVICES ARE INTENDED FOR ONE-TIME USE. A PER INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE, REMOVAL OR REPLACEMENT OF A RESONANCE STENT IS STANDARD PROCEDURE. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INDWELLING URETERAL STENTS INCLUDE URINE DRAINAGE. A FINAL WARNING INDICATES THAT "INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE". PRIOR TO DISTRIBUTION ALL RESONANCE STENT DEVICES ARE SUBJECT TO VISUAL INSPECTIONS TO ENSURE DEVICE INTEGRITY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE RESONANCE STENT WAS NOT DRAINING AND THE PATIENT'S CREATININE LEVELS KEPT INCREASING. THE PHYSICIANS PERFORMED A NEPHROSTOMY DRAINAGE AND EVOLUTION OF FILTRATE WAS CHANGED. THE RESONANCE STENT WAS REMOVED FROM THE PATIENT. FOLLOWING INTERVENTION, THE PATIENT RECOVERED AND CREATININE LEVELS WENT BACK TO NORMAL. NO FURTHER ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350880 RESONANCE STENT SET FAD COOK IRELAND LTD C1021946

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention