BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER

    MDR report key: 10507846 · Received September 9, 2020

    Report

    Report Number
    3001845648-2020-00593
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    June 13, 2019
    Report Date
    October 12, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    PMA / PMN Number
    K063742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION PERTAINING TO SECTION F. 3 AS FOLLOWS: (B)(6). THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. THIS FILE WAS OPENED TO CAPTURE 14 CASES OF THE INCORRECT WIRE GUIDE SIZE BEING USED. ON REVIEW OF THIS COMPLAINT WITH QUALITY ENGINEERING IT WAS DECIDED THAT THIS USER ERROR WILL BE INCLUDED IN THE INVESTIGATION OF REPORTS# 3001845648-2020-00590,3001845648-2020-00591 AND 3001845648-2020-00592 AND THIS COMPLAINT REPORT WILL BE CANCELLED AS IS NO LONGER REQUIRED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. THIS FILE WAS OPENED TO CAPTURE 14 CASES OF THE INCORRECT WIRE GUIDE SIZE BEING USED. ON REVIEW OF THIS COMPLAINT WITH QUALITY ENGINEERING IT WAS DECIDED THAT THIS USER ERROR WILL BE INCLUDED IN THE INVESTIGATION OF REPORTS# 3001845648-2020-00590, 3001845648-2020-00591 AND 3001845648-2020-00592 AND THIS COMPLAINT REPORT WILL BE CANCELLED AS IS NO LONGER REQUIRED. INITIAL REPORT DETAILS: NAVETTA, 2019 ¿TANDEM RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER FOR SALVAGE MANAGEMENT OF CHRONIC URETERAL OBSTRUCTION.¿ NUMBER OF DEVICES: 14 STENTS IN 4 PATIENTS. BRIEF DESCRIPTION: NAVETTA 2019 - ¿USER ERROR". DESCRIPTION OF EVENT: INCORECT WIREGUIDE SIZE USED. A 0.035 HYDROPHILIC GUIDEWIRE WAS USED. RECOMMENDED TO USE WITH WIRE GUIDE 0.038¿ DIAMETER. AS PER LITERATURE PAPER; ''SEVEN RENAL UNITS FROM FOUR PATIENTS WITH A MEDIAN AGE OF 62 YEARS WERE MANAGED WITH TRS.' AND 'CYSTOSCOPICALLY, A 0.035 HYDROPHILIC GUIDEWIRE IS USED TO CANNULATE THE AFFECTED URETERAL ORIFICE AND IS ADVANCED INTO THE RENAL PELVIS UNDER FLUOROSCOPIC GUIDANCE.'' PLEASE NOTE: THE PAPER DESCRIBES THE TANDEM PLACEMENT OF RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER. IT GOES ON TO STATE THAT SEVEN RENAL UNITS FROM FOUR PATIENTS WERE MANAGED WITH TRS. THEREFORE, AS TWO RMS STENTS WERE PLACED SIMULTANEOUSLY SIDE BY SIDE IN SEVEN RENAL UNITS THAT EQUATES TO A TOTAL OF 14 RMS STENTS BEING PLACED. THIS FILE WILL CAPTURE 14 CASES OF THE INCORRECT WIRE GUIDE SIZE BEING USED. PLEASE ALSO NOTE, ALTHOUGH WE CANNOT CONFIRM THE EXACT RPN OF THE RESONANCE METALLIC DOUBLE-J URETERAL STENTS USED IT HAD THE POTENTIAL TO BE ANY ONE OF THE FOLLOWING: RMS-060012-R, RMS-060014-R, RMS-060016-R, RMS-060018-R, RMS-060020-R, RMS-060022-R, OR RMS-060024-R. RMS-060026-R RMS-060028-R RMS-060030-R

    Additional Manufacturer Narrative · 1

    DIVISION OF UROLOGY, DEPARTMENT OF SURGERY, SCOTT & WHITE MEDICAL CENTER¿TEMPLE, TEMPLE, TEXAS. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    NAVETTA, 2019 ¿TANDEM RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER FOR SALVAGE MANAGEMENT OF CHRONIC URETERAL OBSTRUCTION¿. NUMBER OF DEVICES: 14 STENTS IN 4 PATIENTS. BRIEF DESCRIPTION: NAVETTA 2019 - ¿USER ERROR". DESCRIPTION OF EVENT: INCORRECT WIREGUIDE SIZE USED. A 0.035 HYDROPHILIC GUIDEWIRE WAS USED. RECOMMENDED TO USE WITH WIRE GUIDE 0.038¿ DIAMETER. AS PER LITERATURE PAPER; ''SEVEN RENAL UNITS FROM FOUR PATIENTS WITH A MEDIAN AGE OF 62 YEARS WERE MANAGED WITH TRS.' AND 'CYSTOSCOPICALLY, A 0.035 HYDROPHILIC GUIDEWIRE IS USED TO CANNULATE THE AFFECTED URETERAL ORIFICE AND IS ADVANCED INTO THE RENAL PELVIS UNDER FLUOROSCOPIC GUIDANCE''. PLEASE NOTE: THE PAPER DESCRIBES THE TANDEM PLACEMENT OF RESONANCE METALLIC DOUBLE-J URETERAL STENTS IN A SINGLE URETER. IT GOES ON TO STATE THAT SEVEN RENAL UNITS FROM FOUR PATIENTS WERE MANAGED WITH TRS. THEREFORE, AS TWO RMS STENTS WERE PLACED SIMULTANEOUSLY SIDE BY SIDE IN SEVEN RENAL UNITS THAT EQUATES TO A TOTAL OF 14 RMS STENTS BEING PLACED. THIS FILE WILL CAPTURE 14 CASES OF THE INCORRECT WIRE GUIDE SIZE BEING USED. PLEASE ALSO NOTE, ALTHOUGH WE CANNOT CONFIRM THE EXACT RPN OF THE RESONANCE METALLIC DOUBLE-J URETERAL STENTS USED IT HAD THE POTENTIAL TO BE ANY ONE OF THE FOLLOWING: RMS-060012-R, RMS-060014-R, RMS-060016-R, RMS-060018-R, RMS-060020-R, RMS-060022-R, RMS-060024-R, RMS-060026-R, RMS-060028-R, RMS-060030-R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974379 RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER FAD STENT, URETERAL FAD COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR