COTTON-LEUNG BILIARY STENT
Report
- Report Number
- 3001845648-2018-00433
- Event Type
- Malfunction
- Date Received
- September 17, 2018
- Date of Event
- August 21, 2018
- Report Date
- November 12, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO (B)(4).: IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
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. (B)(4) DEVICE EVALUATION: AS THE PRODUCT WAS NOT RETURNED AND THERE WAS NO LOT NUMBER PROVIDED A VERY LIMITED DOCUMENTATION BASED INVESTIGATION WAS COMPLETED. THE CLSO-10-7 DEVICE OF UNKNOWN LOT NUMBER WHICH IS INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR A LAB EVALUATION. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE CLSO-10-7 DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE COMPLETED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. UPON REVIEW OF THE COMPLAINTS HISTORY, THIS FAILURE HAS NOT OCCURRED PREVIOUSLY WITH THIS PRODUCT FAMILY. PRIOR TO DISTRIBUTION, ALL CLSO-10-7 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. IT SHOULD BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE (IFU0045-6) STEP 4 THE USER IS INSTRUCTED TO ¿ADVANCE GUIDING CATHETER* AND/OR PUSHING CATHETER IN 1-2CM INCREMENTS UNTIL STENT IS IN THE DESIRED POSITION¿. CONTRAINDICATIONS SECTION THE USER IS ADVISED THAT "AN INABILITY TO PASS WIRE OR STENT THROUGH THE OBSTRUCTED AREA" IS CONTRAINDICATED. ROOT CAUSE: THE FAILURE OF "ADVANCEMENT DIFFICULT" WAS CONCLUDED FROM THE AVAILABLE INFORMATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE WIRE BECOMING TRAPPED ON THE ELEVATOR PREVENTING ADVANCEMENT OF THE DEVICE. INPUT WAS SOUGHT FROM ENGINEERING TO COME TO THIS CONCLUSION WHERE IT WAS STATED THAT IF THE WIREGUIDE (NOT PART OF OUR KIT) BECAME TRAPPED BY THE ELEVATOR ON THE V SCOPE BY SLIPPING DOWN AT THE BACK OF THE ELEVATOR AND BECOMING PINCHED. THIS WOULD BE SOMETHING THAT THE PHYSICIAN WOULD NOT BE ABLE TO SEE WITH THE CAMERA ON THE ENDOSCOPE AND THEREFORE THEY MOST LIKELY WERE NOT AWARE OF IT ACTUALLY HAPPENING. IN THE COMPLAINT DESCRIPTION IT WAS REPORTED THAT THE WIREGUIDE WOULD NOT ADVANCE AND THAT THE CLSO-10-7 GOT STUCK IN THE WORKING CHANNEL. WITH THE WIREGUIDE TRAPPED ON THE REAR SIDE OF THE ELEVATOR WHEN THE STENT WAS ADVANCED WITH THE OA IT COULD ONLY ADVANCE AS FAR AS THE PINCH POINT. WHEN THE ENDOSCOPE WAS REMOVED THE WIREGUIDE MOST LIKELY BECAME FREE AGAIN, THIS WOULD EXPLAIN WHY THE DELIVERY SYSTEM AND STENT WERE EASILY REMOVED USING THE CLEANING BRUSH AS DESCRIBED. AS NO OTHER DEBRIS WAS REMOVED THE ONLY THING THAT WOULD LIKELY HAVE CAUSED THE OBSTRUCTION WAS THE WIREGUIDE GETTING CAUGHT ON THE ELEVATOR. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO 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)(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.
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT." AS REPORTED TO CUSTOMER RELATIONS, "BECAME STUCK IN A DUODENOSCOPE (4.2MM CHANNEL)."
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT" AS REPORTED TO CUSTOMER RELATIONS, "BECAME STUCK IN A DUODENOSCOPE (4.2MM CHANNEL)."
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT" AS REPORTED TO CUSTOMER RELATIONS, "BECAME STUCK IN A DUODENOSCOPE (4.2MM CHANNEL)."
THIS COMPLAINT IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT" AS REPORTED TO CUSTOMER RELATIONS, "BECAME STUCK IN A DUODENOSCOPE (4.2MM CHANNEL)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724370 | COTTON-LEUNG BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |