COTTON-LEUNG BILIARY STENT
Report
- Report Number
- 3001845648-2018-00385
- Event Type
- Malfunction
- Date Received
- August 16, 2018
- Date of Event
- July 18, 2018
- Report Date
- October 11, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 00827002219878
- PMA / PMN Number
- K851962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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: K851962. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER: K851962. 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). ADDITIONAL INFORMATION; WHAT INTRODUCTION SYSTEM WAS USED TO ADVANCE THE STENT? THEY USED THE PC-7 FOR ADVANCING THE STENT. WAS THE ANATOMY TORTUOUS? NO, THE ANATOMY WAS COMMON. DOES THE CUSTOMER BELIEVE THE STENT COULD NOT PASS THE STRICTURE BECAUSE THE STRICTURE WAS VERY TIGHT AND PERHAPS THE STENT MATERIAL WAS TOO SOFT TO PASS? THE CUSTOMER WAS THINKING ABOUT BOTH REASONS. WHAT STENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE? THE CUSTOMER ENDED THE PROCEDURE AFTER USING OUR PRODUCT IN THE SAME SIZE. WHAT PRODUCT WAS USED TO REMOVE THE STENT? FORCEPS? THEY USED FORCEPS. LAB EVALUATION: 1 X CLSO-7-14 DEVICE OF LOT # C1377228 WAS RETURNED TO CIRL FOR EVALUATION. A LAB EVALUATION WAS HELD ON 27 AUG 2018. UPON EVALUATION OF THE RETURNED DEVICE THE MIDDLE OF THE STENT WAS FOUND TO BE PINCHED. NO OTHER DAMAGE OR DEFECTS WERE OBSERVED. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AS THE CLINICAL SETTINGS THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD RELATE TO THE PATIENT ANATOMY AND A TIGHT STRICTURE. THE CUSTOMER HAS A TIGHT STRICTURE AND THE STENT MATERIAL TYPE OR SIZE MAY HAVE CONTRIBUTED TO THE FAILURE OF THE STENT TO PASS THE STRICTURE. 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. DOCUMENT REVIEW: A REVIEW OF MANUFACTURING RECORDS FOR LOT # C1377228 DID NOT REVEAL ANY DISCREPANCY RELATED TO THE COMPLAINT ISSUE. PRD/FQC/PKG REVIEW : PRIOR TO DISTRIBUTION ALL CLSO-7-14 DEVICES ARE SUBJECT TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY; THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL THERE WAS ALSO 100% VISUAL INSPECTION OF PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC AND POST STERILE QC. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0045-6, A CONTRAINDICATIONS IDENTIFIED INCLUDES AN ¿INABILITY TO PASS WIREGUIDE OR STENT THROUGH OBSTRUCTED AREA¿ AND THE USER IS ALSO INSTRUCTED TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY 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. HOWEVER, IT IS POSSIBLE THAT A TIGHT STRICTURE MAY HAVE CONTRIBUTED TO THE FAILURE OF THE STENT TO PASS THE STRICTURE. THE COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY AND A PINCH WAS OBSERVED IN THE MIDDLE OF THE STENT. WHICH IS CONSISTENT WITH REMOVAL BY FORCEPS. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY AS THE CLINICAL SETTINGS THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510(K) NUMBER: K851962. (B)(4). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (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". THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT.
THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT". THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT.
THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "DIFFICULT ADVANCEMENT" THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT.
THEY TRIED TO PUT THE STENT IN THE BILE DUCT, BUT THE STENT COULD NOT PASS THROUGH THE STRICTURE IN THE BILE DUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630943 | COTTON-LEUNG BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | G21987 | C1377228 | 00827002219878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |