EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
Report
- Report Number
- 3001845648-2018-00339
- Event Type
- Malfunction
- Date Received
- July 26, 2018
- Date of Event
- June 29, 2018
- Report Date
- August 23, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002231297
- PMA / PMN Number
- K121430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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.
510(K) NUMBER: K121430 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). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT: AS PER COMPLAINT FORM: ¿SHEATH AND CORE OF DELIVERY SYSTEM BROKEN. USER ADVANCED THE DELIVERY SYSTEM INTO ENDOSCOPY CHANNEL AND TRIED TO RELEASE BY PULLING THE TRIGGER BUT MET OBVIOUS RESISTANCE. USER TRIED AGAIN BUT TURNED OUT THE DELIVERY SYSTEM SHEATH AND CORE BROKEN. SEE ATTACHED PICTURES. USER CHANGED ANOTHER COOK 365 STENT FINISHED THE PROCEDURE.¿ A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL QUESTIONS RECEIVED: GENERAL QUESTIONS: 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR?(WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL)STENT PLACEMENT 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED?OLYMPUS GIF-Q260J. 3. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? CLOSED. 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)?BOSTON ZEBRA WIRE GUIDE 0.035. 5. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES. 6. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? NONE. 7. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETE AND HOW OFTEN? NONE. STRICTURE INFORMATION: 1. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? 4CM/3MM. 2. WHERE WAS THE STRICTURE LOCATED IN THE BODY? UPPER MIDDLE SEGMENT OF HILAR BILE DUCT . 3. WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THROUGH STRICTURE? NO. 4. WAS THERE RESISTANCE FELT PASSING THE EVOLUTION THROUGH STRICTURE? YES. 5. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? YES. QUESTIONS RELATED TO DURING INSERTION INTO PATIENT: 1. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES. NO KINKS OR DAMAGE. 2. WAS RESISTANCE FELT DURING INSERTION INTO PATIENT? IF YES, AT WHAT POINT? YES. QUESTIONS RELATED TO DURING STENT PLACEMENT: 1. DID THE PRODUCT FAIL DURING STENT DEPLOYMENT OR RECAPTURE?YES. THE STENT CANNOT BE RELEASE. 2. WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? YES, TWICE. 3. WAS ANY PART OF THE STENT OBSERVED IN CONTACT WITH THE PATIENT¿S ANATOMY AT THE TIME OF FAILURE? NO. 4. WAS THE YELLOW MARKER KEPT IN VIEW DURING DEPLOYMENT? NO. 5. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? ATTACHED. QUESTIONS RELATED TO DURING INTRODUCER WITHDRAWAL: 1. WAS FINAL STENT PLACEMENT CONFIRMED USING ENDOSCOPY / FLUOROSCOPY? IF YES, WHAT WAS USED? 2. DID THE STENT OPEN SUFFICIENTLY TO ALLOW WITHDRAWAL OF INTRODUCER SAFELY? 3. WAS THE SAFETY WIRE FULLY REMOVED BEFORE REMOVING THE DELIVERY SYSTEM? 4. DID ANY PART OF THE PRODUCT SNAG/GET CAUGHT WITH THE STENT WHEN REMOVING THE DELIVERY SYSTEM? 5. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? QUESTIONS RELATED TO DURING STENT REPOSITIONING/REMOVAL: 1. WHAT INSTRUMENT WAS USED FOR STENT REPOSITIONING / REMOVAL? FORCEPS, SNARE¿ 2. WAS THE LASSO (SUTURE) LOOP USED DURING REPOSITIONING / REMOVAL? DEVICE EVALUATION: THE EVO-10-11-8-B DEVICE OF LOT NUMBER C1429793 WAS RETURNED TO CIRL AND EVALUATED ON THE 25-JULY-2018. LAB EVALUATION: UPON REVIEW OF THE RETURNED DEVICE, DEVICE WAS NOTED TO HAVE RETURNED IN MULTIPLE PIECES. OUTER SHEATH WAS BROKEN PROXIMAL TO SHUTTLE CAP. PROXIMAL FLEXOR WAS BROKEN. RETRIEVAL LOOP CANNULA WAS BROKEN. IT WAS NOTED THAT YELLOW COGS AND OTHER INTERNAL COMPONENTS OF THE HANDLE WERE MISSING. STENT WAS MANUALLY DEPLOYED. THE DEFECT WAS DETERMINED BY VISUAL INSPECTION. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ROOT CAUSE: BASED ON THE INFORMATION PROVIDED THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS THAT A KINK MAY HAVE OCCURRED AT SOME STAGE DURING THE PROCEDURE DUE TO TORTUOUS ANATOMY AND THIS CAUSED A BUILD-UP OF PRESSURE AND THIS MAY HAVE RESULTED IN THE OUTER SHEATH BREAKING PROXIMAL TO SHUTTLE CAP. THE CUSTOMER TRIED TO MANUALLY DEPLOY STENT AND CAUSED ALL OTHER FAILURES IN THE DEVICE. ELEVATOR POSSIBLE CONTRIBUTING FACTOR. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL EVO-10-11-8-B DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-10-11-8-B DEVICE OF LOT NUMBER C1429793 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1429793; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1429793. IFU REVIEW: THE INSTRUCTIONS FOR USE IFU0061-5 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER 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". ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE OUTER SHEATH WAS BROKEN PROXIMAL TO THE SHUTTLE CAP. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS COMPLAINT IS BEING REPORTED UNDER THE MALFUNCTION PRECEDENCE "FLEXOR KINKED/ STRETCHED/ BROKE/ COMPRESSED" USER ADVANCED THE DELIVERY SYSTEM INTO ENDOSCOPY CHANNEL AND TRIED TO RELEASE BY PULLING THE TRIGGER BUT MET OBVIOUS RESISTANCE. USER TRIED AGAIN BUT TURNED OUT THE DELIVERY SYSTEM SHEATH AND CORE BROKEN. USER CHANGED ANOTHER COOK 365 STENT FINISHED THE PROCEDURE.
THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE CONCLUSIONS OF THE INVESTIGATION. USER ADVANCED THE DELIVERY SYSTEM INTO ENDOSCOPY CHANNEL AND TRIED TO RELEASE BY PULLING THE TRIGGER BUT MET OBVIOUS RESISTANCE. USER TRIED AGAIN BUT TURNED OUT THE DELIVERY SYSTEM SHEATH AND CORE BROKEN. SEE ATTACHED PICTURES. USER CHANGED ANOTHER COOK 365 STENT FINISHED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565944 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G23129 | C1429793 | 10827002231297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |