BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 7776098 · Received August 13, 2018

    Report

    Report Number
    3001845648-2018-00374
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 16, 2018
    Report Date
    July 17, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    UDI-DI
    10827002341118
    PMA / PMN Number
    K063742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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)(6). (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION: 1 X RMS-060026-R DEVICE OF LOT # C1473997 INVOLVED IN THIS COMPLAINT WAS RETURNED TO CIRL AND A LAB EVALUATION WAS HELD ON 16 AUG 2018. DURING THE LAB EVALUATION IT WAS NOTED THAT ONLY THE OUTER SHEATH / INTRODUCTION CATHETER WAS RETURNED. THE SHEATH WAS RETURNED BROKEN INTO TWO PIECES. THE SHEATH WAS ALSO FOUND TO BE KINKED AT THE PROXIMAL END NEAR THE HUB WHICH IS LIKELY RELATED TO THE STENT BREAK. THE STENT WAS NOT RETURNED WITH THE DEVICE. DOCUMENTS REVIEW: A REVIEW OF MANUFACTURING RECORDS FOR THE METAL RESONANCE STENT SETS FOR LOT # C1473997 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1473997 UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1473997. A REVIEW OF SUB ASSEMBLY RESONANCE CLEAR SHEATH STENT INTRODUCER' DETERMINED THAT ONE SHEATH WAS SCRAPPED AS IT MEASURED TOO SHORT, HOWEVER IT IS NOT LIKELY THAT THIS DISCREPANCY IS RELATED TO THE COMPLAINT ISSUE AS THE NON-CONFORMING UNIT WAS SCRAPPED AND REPLACED WITH A UNIT FROM SUB ASSEMBLY CH1464200. COMPONENTS SUPPLIED BY EXTERNAL SUPPLIERS ARE SUBJECT TO INCOMING INSPECTION IN COOK IRELAND AND WERE ACCEPTED. PRDS/FQC REVIEW: PRIOR TO DISTRIBUTION ALL 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" AND TO "MANUALLY TUG THE BLACK BAND AT THE DISTAL END OF THE SHEATH TO ENSURE IT IS SECURE, VISUALLY INSPECT THE JOINT SEAM FOR ANY CRACKS OR SEPARATION". THERE WAS ALSO 100% VISUAL INSPECTION OF PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC AND POST STERILE QC. IFU REVIEW: ACCORDING TO THE INSTRUCTIONS FOR USE 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." ROOT CAUSE: 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. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESS PRESSURE BEING PLACED ON THE CATHETER DURING USE, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY AND THE CATHETER SHEATH WAS FOUND TO BE BROKEN. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY AND THE CATHETER SHEATH WAS FOUND TO BE BROKEN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS "THEY HAD THE CLEAR CATHETER IN PLACE. AS THE PHYSICIAN WAS REPOSITIONING THE CATHETER, THE CATHETER BROKE. THEY WERE THEN UNABLE TO USE THE CATHETER TO PLACE THE STENT. PART OF THE CATHETER WAS ALREADY OUT OF THE PATIENT'S BODY. THE OTHER BROKEN CATHETER PART WAS RETRIEVED WITH GRASPERS DURING THE PROCEDURE. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER STENT OF THE SAME TYPE."

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS "THEY HAD THE CLEAR CATHETER IN PLACE. AS THE PHYSICIAN WAS REPOSITIONING THE CATHETER, THE CATHETER BROKE. THEY WERE THEN UNABLE TO USE THE CATHETER TO PLACE THE STENT. PART OF THE CATHETER WAS ALREADY OUT OF THE PATIENT'S BODY. THE OTHER BROKEN CATHETER PART WAS RETRIEVED WITH GRASPERS DURING THE PROCEDURE. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER STENT OF THE SAME TYPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618853 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD G34111 C1473997 10827002341118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention