FGE CATHETER, BILIARY, DIAGNOSTIC
Report
- Report Number
- 3001845648-2018-00412
- Event Type
- Malfunction
- Date Received
- September 6, 2018
- Report Date
- October 4, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K121430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
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. ADDITIONAL INFORMATION RECEIVED: 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) THE COMPLAINTS HAPPENED WHEN RELEASING THE STENT COMPLETELY, THE STENT COULDN¿T COMPLETELY BE DETACHED FROM THE DELIVERY SYSTEM. 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? DUODENOSCOPE. 3. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? MOST LIKELY 0.035 INCH ERCP WIRE. 5. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? YES, THE METAL STENT WAS IN THE BILIARY DUCT (ONLY 1CM OUTSIDE OF PAPILLA). 6. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? JUST BEEN TRIED TO DEPLOY, SO FROM 10 SECONDS TO ABOUT 2 MINUTES. 7. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETE AND HOW OFTEN? STRICTURE INFORMATION: 1. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? NA AND DIFFERENT CASES THAT IT HAPPENED. 2. WHERE WAS THE STRICTURE LOCATED IN THE BODY? BILIARY DUCT. 3. WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THROUGH STRICTURE? NA. 4. WAS THERE RESISTANCE FELT PASSING THE EVOLUTION THROUGH STRICTURE? NA. 5. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NA. QUESTIONS RELATED TO DURING INSERTION INTO PATIENT: 1. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? NO KINKS SEEMED OBVIOUS. 2. WAS RESISTANCE FELT DURING INSERTION INTO PATIENT? IF YES, AT WHAT POINT? NA. QUESTIONS RELATED TO DURING STENT PLACEMENT: 1. DID THE PRODUCT FAIL DURING STENT DEPLOYMENT OR RECAPTURE? DURING STENT DEPLYOMENT. 2. WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? YES, DIRECTIONAL BUTTON WAS IN RELEASE POSITION. 3. WAS ANY PART OF THE STENT OBSERVED IN CONTACT WITH THE PATIENT¿S ANATOMY AT THE TIME OF FAILURE? YES THE STENT/DELIVERY SYSTEM WAS IN CONTACT WITH THE BILIARY DUCT. 4. WAS THE YELLOW MARKER KEPT IN VIEW DURING DEPLOYMENT? YES. 5. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. QUESTIONS RELATED TO DURING INTRODUCER WITHDRAWAL: 1. WAS FINAL STENT PLACEMENT CONFIRMED USING ENDOSCOPY / FLUOROSCOPY? IF YES, WHAT WAS USED? BOTH. 2. DID THE STENT OPEN SUFFICIENTLY TO ALLOW WITHDRAWAL OF INTRODUCER SAFELY? YES, STENT SEEMED TO BE FULLY OPEN, ONLY FOR LAST LASSO WAS NOT RELEASED FROM INTRODUCTION SYSTEM. 3. WAS THE SAFETY WIRE FULLY REMOVED BEFORE REMOVING THE DELIVERY SYSTEM? SAFETY WIRE WAS SAID TO BE PULLED. 4. DID ANY PART OF THE PRODUCT SNAG/GET CAUGHT WITH THE STENT WHEN REMOVING THE DELIVERY SYSTEM? YES, THE LASSO SEEMED TO BE STILL ATTACHED TO DELIVERY SYSTEM, THEREFORE THE ENDOSCOPE MANEUVER WAS PERFORMED (AS TRIGGER WAS COMPLETELY PUSHED). WITH ENDOSCOPE MOVEMENT RELEASE WAS POSSIBLE. 5. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO NOT AVAILABLE. QUESTIONS RELATED TO DURING STENT REPOSITIONING/REMOVAL: 1. WHAT INSTRUMENT WAS USED FOR STENT REPOSITIONING / REMOVAL? STENT WAS NOT REMOVED AND NOT REPOSITIONED- ENDOSCOPE MANOEUVRE WAS PERFORMED FOR RELEASE OF STENT FROM DELIVERY SYSTEM. 2. WAS THE LASSO (SUTURE) LOOP USED DURING REPOSITIONING / REMOVAL? STENT WAS NOT REMOVED AND NOT REPOSITIONED- ENDOSCOPE MANOEUVRE WAS PERFORMED FOR RELEASE OF STENT FROM DELIVERY SYSTEM. WAS THE COLOUR OF THE LOOP THAT THEY MENTION DEFINITELY YELLOW? YES THEY MENTIONED IT TO BE YELLOW. DEVICE EVALUATION: THE EVO FULLY COVERED DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND AND SO COULD NOT BE EVALUATED. LAB EVALUATION: AS THE DEVICE WAS NOT RETURNED; A LAB EVALUATION COULD NOT BE CONDUCTED. ROOT CAUSE: A POSSIBLE CAUSE FOR THE DEPLOYMENT DIFFICULTY RELATED TO THE RELEASE OF STENT IS POSSIBLY DUE TO TORTUROUS ANATOMY. THE PHYSICIAN HASN¿T STATED THAT DILATION OF THE SITE WAS PERFORMED PRIOR TO THE PLACEMENT PROCEDURE WHICH WOULD COUNTERACT THE TORTUROUS ANATOMY. THIS WAS CONFIRMED BY ENGINEERING. HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. DOCUMENT REVIEW: WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE EXACT RPN WAS NOT PROVIDED. INFORMATION WAS PROVIDED THAT ONE COMPLAINT WAS FULLY COVERED AND ONE COMPLAINT WAS PARTIALLY COVERED. THEREFORE, THIS FILE HAS ASSESSED FOR THE EVO FULLY COVERED DEVICE & AN ADDITIONAL FILE WAS ASSESSED FOR THE EVO PARTIALLY COVERED DEVICE. PRIOR TO DISTRIBUTION ALL EVO FULLY COVERED 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. IFU REVIEW: AS PER THE INSTRUCTIONS FOR USE, IFU0056-5, NOTES SECTION THE USER IS INSTRUCTED OF THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". SUMMARY: THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER TESTIMONY, AS THE DEVICE WAS NOT RETURNED FOR LAB EVALUATION. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS
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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
REPORT IS BEING SUBMITTED BASED ON THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF "DEPLOYMENT ISSUE WHICH RESULTS IN THE EXPOSED STENT BEING REMOVED FROM THE PATIENT". THE PHYSICIAN COMPLAINT THAT IN SOME CASES THE YELLOW COATED RETRIEVAL LOOP OF THE PARTIALLY OR FULLY COVERED EVOLUTION METAL STENT WAS CLAMPED/TRAPPED IN THE CATHETER AND THE STENT COULDN'T RELEASE EASILY. AN ENDOSCOPE TURNING/MOVEMENT WAS NECESSARY TO RELEASE THE RETRIEVAL LOOP FROM THE EVOLUTION CATHETER; THAT COULD HAVE MAKE THE STENT MOVE AS WELL. THE PHYSICIAN STATED THAT THE TRIGGER WAS FULLY PUSHED ALL WAY AND THE SAFETY WIRE WAS REMOVED.
REPORT IS BEING SUBMITTED BASED ON THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF "DEPLOYMENT ISSUE WHICH RESULTS IN THE EXPOSED STENT BEING REMOVED FROM THE PATIENT". THE PHYSICIAN COMPLAINT THAT IN SOME CASES THE YELLOW COATED RETRIEVAL LOOP OF THE PARTIALLY OR FULLY COVERED EVOLUTION METAL STENT WAS CLAMPED/TRAPPED IN THE CATHETER AND THE STENT COULDN'T RELEASE EASILY. AN ENDOSCOPE TURNING/MOVEMENT WAS NECESSARY TO RELEASE THE RETRIEVAL LOOP FROM THE EVOLUTION CATHETER; THAT COULD HAVE MAKE THE STENT MOVE AS WELL. THE PHYSICIAN STATED THAT THE TRIGGER WAS FULLY PUSHED ALL WAY AND THE SAFETY WIRE WAS REMOVED.
REPORT IS BEING SUBMITTED BASED ON THE REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF "DEPLOYMENT ISSUE WHICH RESULTS IN THE EXPOSED STENT BEING REMOVED FROM THE PATIENT". THE PHYSICIAN COMPLAINT THAT IN SOME CASES THE YELLOW COATED RETRIEVAL LOOP OF THE PARTIALLY OR FULLY COVERED EVOLUTION METAL STENT WAS CLAMPED/TRAPPED IN THE CATHETER AND THE STENT COULDN'T RELEASE EASILY. AN ENDOSCOPE TURNING/MOVEMENT WAS NECESSARY TO RELEASE THE RETRIEVAL LOOP FROM THE EVOLUTION CATHETER; THAT COULD HAVE MAKE THE STENT MOVE AS WELL. THE PHYSICIAN STATED THAT THE TRIGGER WAS FULLY PUSHED ALL WAY AND THE SAFETY WIRE WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693904 | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |