BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESONANCE STENT SET

    MDR report key: 7718096 · Received July 25, 2018

    Report

    Report Number
    3001845648-2018-00332
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 24, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    UDI-DI
    10827002341118
    PMA / PMN Number
    K063742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE; "UNABLE TO ADVANCE THE STENT DUE TO A KINK IN THE SHEATH". ADDITIONAL INFORMATION: THE DEVICE WAS USED FOR TRANSURETHRAL URETERAL STENT PLACEMENT FOR URETERAL STENOSIS DUE TO RETROPERITONEAL FIBROSIS. AFTER ADVANCING A WIRE GUIDE TO THE RENAL PELVIS, THE PHYSICIAN ADVANCED THE COMBINED INTRODUCTION CATHETER AND SHEATH UNDER FLUOROSCOPIC GUIDANCE OVER THE WIRE GUIDE. CONTRAST MEDIA WAS INJECTED THROUGH THE INTRODUCTION CATHETER AND SHEATH TO CHECK THE POSITION OF THE RENAL PELVIS AND UPJ FOR RECONFIRMATION OF THE TARGET PLACEMENT SITE. AFTER THAT, THE INTRODUCTION CATHETER WAS REMOVED, THEN THE STENT WAS INSERTED AND ADVANCED WITH THE INTRODUCTION CATHETER. HOWEVER, THE STENT STOPPED ADVANCING AROUND THE DISTAL URINARY DUCT. THE USER PUSHED THE STENT WITH SOME MORE FORCE, BUT IT WOULD NOT ADVANCE. HE JUDGED THAT SOME ISSUE OCCURRED ON THE SHEATH, SO HE CUT THE SHEATH AND REMOVED THE STENT ONCE. AFTER CONFIRMING THAT THE SHEATH WAS STILL IN THE URINARY DUCT, HE ADVANCED THE WIRE GUIDE AGAIN FOR ANOTHER TRY. A KINK WAS NOTED IN THE REMOVED SHEATH. THE STENT WAS PLACED SUCCESSFULLY BY USING ANOTHER INTRODUCTION CATHETER AND SHEATH WHICH WERE USED PREVIOUSLY TO PLACE A STENT IN THE CONTRALATERAL SIDE. ¿THE USER PUSHED THE STENT WITH SOME MORE FORCE, BUT IT WOULD NOT ADVANCE. HE JUDGED THAT SOME ISSUE OCCURRED ON THE SHEATH, SO HE CUT THE SHEATH AND REMOVED THE STENT ONCE¿. ADDITIONAL INFORMATION REQUESTED AFTER LAB EVALUATION: DID INNER SHEATH ADVANCE TO THE KIDNEY? WOULD YOU CLARIFY WHAT ¿INNER SHEATH¿ MEANS? IS IT THE ¿INTRODUCTION CATHETER¿ PLACED INSIDE THE SHEATH? IF SO, AT WHAT POINT DID YOU MEAN? USUALLY, COMBINED INTRODUCTION CATHETER AND SHEATH WHICH IS CALLED ¿INTRODUCTION CATHETER AND SHEATH¿ ARE ADVANCED INTO THE PATIENT FIRST, THEN THE INTRODUCTION CATHETER IS REMOVED FROM THE SHEATH, THEN INSERTED GAIN TO PUSH A STENT THROUGH THE SHEATH. THERE ARE SOME POINTS TO ADVANCE THE INTRODUCTION CATHETER. AT WHAT POINT WAS DEVICE KINKED ? THE SHEATH WAS RETURNED TO CIR, SO PLEASE INSPECT IT AT YOUR FACILITY. AT WHAT POINT DID THEY NOTICE THE KINK? PLEASE SEE DESCRIPTION OF EVENT IN TRACKWISE; ¿THE USER PUSHED THE STENT WITH SOME MORE FORCE, BUT IT WOULD NOT ADVANCE. HE JUDGED THAT SOME ISSUE OCCURRED ON THE SHEATH, SO HE CUT THE SHEATH AND REMOVED THE STENT ONCE¿ IN RESPONSE TO THE REQUEST BY THE PHYSICIAN AND SALES REP CONCERNING THE NUMBER OF ADVANCEMENT FAILURES DUE TO KINKED SHEAT WE HAVE REVIEWED THE RECORDS OVER THE PASS THREE YEARS (B)(6) 2015 - (B)(6) 2018 AND WE HAVE RECEIVED 4 COMPLAINTS FOR KINKING FOR THIS PRODUCT IN THIS TIME PERIOD. 1 X RMS-060026-R DEVICE OF LOT # C1456852 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE A KINK WAS OBSERVED ON THE PROXIMAL END OF THE SHEATH. THE OUTER SHEATH WAS CUT AND A KINK WAS OBSERVED APPROXIMATELY AT THE POINT OF SCOPE EXIT. THE INNER SHEATH PASSED THROUGH OUTER SHEATH WITH EASE AND PASSED THE KINK. A POSSIBLE ROOT CAUSE FOR THE KINKING IN THE SHEATH MAY BE ATTRIBUTED TO TORTUOUS ANATOMY OR EXCESSIVE FORCE WHEN THE STENT WAS BEING DEPLOYED. 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. THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY AND THE DEVICE WAS FOUND TO BE DAMAGED. A REVIEW OF MANUFACTURING RECORDS FOR THE METAL RESONANCE STENT SETS FOR LOT # C1456852 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL (B)(4) DEVICES ARE SUBJECT TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY; THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS OUTLINED IN INTERNAL PROCEDURES AT CIRL, MTMS ARE INSTRUCTED TO ENSURE THAT THE 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 . 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." 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.

    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

    THE DEVICE WAS USED FOR TRANSURETHRAL URETERAL STENT PLACEMENT FOR URETERAL STENOSIS DUE TO RETROPERITONEAL FIBROSIS. AFTER ADVANCING A WIRE GUIDE TO THE RENAL PELVIS, THE PHYSICIAN ADVANCED THE COMBINED INTRODUCTION CATHETER AND SHEATH UNDER FLUOROSCOPIC GUIDANCE OVER THE WIRE GUIDE. CONTRAST MEDIA WAS INJECTED THROUGH THE INTRODUCTION CATHETER AND SHEATH TO CHECK THE POSITION OF THE RENAL PELVIS AND UPJ FOR RECONFIRMATION OF THE TARGET PLACEMENT SITE. AFTER THAT, THE INTRODUCTION CATHETER WAS REMOVED, THEN THE STENT WAS INSERTED AND ADVANCED WITH THE INTRODUCTION CATHETER. HOWEVER, THE STENT STOPPED ADVANCING AROUND THE DISTAL URINARY DUCT. THE USER PUSHED THE STENT WITH SOME MORE FORCE, BUT IT WOULD NOT ADVANCE. HE JUDGED THAT SOME ISSUE OCCURRED ON THE SHEATH, SO HE CUT THE SHEATH AND REMOVED THE STENT ONCE. AFTER CONFIRMING THAT THE SHEATH WAS STILL IN THE URINARY DUCT, HE ADVANCED THE WIRE GUIDE AGAIN FOR ANOTHER TRY. A KINK WAS NOTED IN THE REMOVED SHEATH. THE STENT WAS PLACED SUCCESSFULLY BY USING ANOTHER INTRODUCTION CATHETER AND SHEATH WHICH WERE USED PREVIOUSLY TO PLACE A STENT IN THE CONTRALATERAL SIDE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Description of Event or Problem · 0

    THE DEVICE WAS USED FOR TRANSURETHRAL URETERAL STENT PLACEMENT FOR URETERAL STENOSIS DUE TO RETROPERITONEAL FIBROSIS. AFTER ADVANCING A WIRE GUIDE TO THE RENAL PELVIS, THE PHYSICIAN ADVANCED THE COMBINED INTRODUCTION CATHETER AND SHEATH UNDER FLUOROSCOPIC GUIDANCE OVER THE WIRE GUIDE. CONTRAST MEDIA WAS INJECTED THROUGH THE INTRODUCTION CATHETER AND SHEATH TO CHECK THE POSITION OF THE RENAL PELVIS AND UPJ FOR RECONFIRMATION OF THE TARGET PLACEMENT SITE. AFTER THAT, THE INTRODUCTION CATHETER WAS REMOVED, THEN THE STENT WAS INSERTED AND ADVANCED WITH THE INTRODUCTION CATHETER. HOWEVER, THE STENT STOPPED ADVANCING AROUND THE DISTAL URINARY DUCT. THE USER PUSHED THE STENT WITH SOME MORE FORCE, BUT IT WOULD NOT ADVANCE. HE JUDGED THAT SOME ISSUE OCCURRED ON THE SHEATH, SO HE CUT THE SHEATH AND REMOVED THE STENT ONCE. AFTER CONFIRMING THAT THE SHEATH WAS STILL IN THE URINARY DUCT, HE ADVANCED THE WIRE GUIDE AGAIN FOR ANOTHER TRY. A KINK WAS NOTED IN THE REMOVED SHEATH. THE STENT WAS PLACED SUCCESSFULLY BY USING ANOTHER INTRODUCTION CATHETER AND SHEATH WHICH WERE USED PREVIOUSLY TO PLACE A STENT IN THE CONTRALATERAL SIDE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562496 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD G34111 C1456852 10827002341118

    Patients

    Seq Age Sex Outcome Treatment
    1