BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONANCE STENT SET

    MDR report key: 7868572 · Received September 12, 2018

    Report

    Report Number
    3001845648-2018-00425
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 15, 2018
    Report Date
    September 12, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    UDI-DI
    10827002341118
    PMA / PMN Number
    K063742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K063742. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. LAB EVALUATION: 1 X RMS-060026-R DEVICE OF LOT # C1468740 WAS RETURNED TO CIRL FOR EVALUATION. A LAB EVALUATION WAS HELD ON 06 SEP 2018. A VISUAL AND FUNCTIONAL EVALUATION WAS CARRIED OUT. THE RETURNED DEVICE WAS BADLY CRUMPLED/COLLAPSED/COMPRESSED AND TWISTED AT APPROXIMATELY 25CM FROM THE MARKER. APPROXIMATELY 4 CM OF DAMAGE WAS OBSERVED. IT WAS BROKEN IN TWO PIECES. ONE PIECE WAS 7 CM INCLUDING THE WHITE HUB. THE OPEN CATHETER PASSED THROUGH THE OUTER SHEATH AND RESISTANCE WAS MET AT THE POINT OF CRUMPLING. THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY AND THE DEVICE WAS FOUND TO BE DAMAGED. DOCUMENT REVIEW: A REVIEW OF MANUFACTURING RECORDS FOR THE METAL RESONANCE STENT SETS FOR LOT # C1468740 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE.: SUB ASSEMBLY COMPONENTS SUPPLIED BY EXTERNAL MANUFACTURERS FOR THE MANUFACTURE OF LOT # C1468740 PASSED INTERNAL INSPECTION WHEN RECEIVED AT COOK IRELAND. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1468740; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1468740. PRDS/FQC REVIEW: PRIOR TO DISTRIBUTION ALL RMS-060026-R DEVICES ARE SUBJECT TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY; THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. MANUFACTURING TEAM MEMBERS ARE INSTRUCTED TO "CHECK SHEATH IS CLEAN AND FREE FROM GREASE OR CONTAMINATION AND NOT KINKED ALONG ITS LENGTH." THERE WAS ALSO 100% VISUAL INSPECTION OF PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC AND POST STERILE QC. "COMPLETE A 100% VISUAL INSPECTION OF THE PACKAGED UNIT (TYVEK POUCHED) WHILE HELD AT COMFORTABLE ARMS LENGTH FROM THE UNAIDED EYE AT NORMAL LIGHTING CONDITIONS". IFU REVIEW: ACCORDING TO THE INSTRUCTIONS FOR USE THE USER IS INSTRUCTED AS FOLLOWS; ¿DO NOT FORCE COMPONENTS DURING REMOVAL OR REPLACEMENT. CAREFULLY REMOVE THE COMPONENTS IF ANY RESISTANCE IS ENCOUNTERED¿. IN THE ¿HOW SUPPLIED¿ SECTION OF THE USER IS INSTRUCTED TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." THE JAPANESE PACKAGING INSERT SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE, OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. ROOT CAUSE: A POSSIBLE ROOT CAUSE FOR THE KINK IN THE SHEATH MAY BE ATTRIBUTED TO TORTUOUS ANATOMY AND THE SHEATH CAUGHT AND TWISTED ON STRICTURE. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY AND THE DEVICE WAS FOUND TO BE DAMAGED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 0

    URETERAL STENT REPLACEMENT WAS PERFORMED TRANSURETHRALLY TO THE PATIENT WHO HAS BEEN PLACED POLYMER STENT IN THE URETERAL. THERE WAS STENOSIS AT LOWER URINARY TRACT AND TORTUOSITY WAS SEEN AT MIDDLE URINARY DUCT. FIRST, RIGID ENDOSCOPE (OLYMPUS 22FR) WAS ADVANCED BY TRANSURETHRALLY AND REMOVED POLYMER STENT. THEN, THE WIRE GUIDE WERE ADVANCED AND URETHRAL CATHETER WAS INSERTED TO PERFORM CONTRAST STUDY OF KIDNEY AND URINARY DUCT. AFTER CONFIRMATION OF THE STENT PLACEMENT LOCATION, THE INTRODUCTION CATHETER AND THE SHEATH WERE ADVANCED INTO RENAL PELVIS UNDER RIGID ENDOSCOPE OVER THE WIRE GUIDE WITHOUT PROBLEMS. THE USER REMOVED THE WIRE GUIDE AND INTRODUCTION CATHETER, THEN, THE STENT WAS ATTEMPTED TO ADVANCE INTO THE SHEATH, HOWEVER THE STENT STOPPED ADVANCING IN THE MIDDLE. THEREFORE, THE USER CUT THE SHEATH WHERE THE OUTSIDE OF THE PATIENT'S BODY, AND THE STENT WAS WITHDRAWN USING HIS HAND. THE WIRE GUIDE WAS ADVANCED INTO THE CUT SHEATH AGAIN TO ENSURE THE URINARY PASSAGE. THE BACK UP DEVICE WHICH WAS THE SAME SIZE WAS USED INSTEAD TO COMPLETE THE PROCEDURE WITH THE SAME STEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711979 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD G34111 C1468740 10827002341118

    Patients

    Seq Age Sex Outcome Treatment
    1