FGE CATHETER, BILIARY, DIAGNOSTIC
Report
- Report Number
- 3001845648-2018-00093
- Event Type
- Injury
- Date Received
- February 28, 2018
- Report Date
- January 22, 2018
- Product Code
- FGE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KR
- Reporter Occupation
- OTHER
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. A 510(K) NUMBER HAS NOT BEEN PROVIDED AS WE HAVE NO INFORMATION TO IDENTIFY THE PRODUCT. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
(B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THIS REPORT IS BEING SUBMITTED AS A CORRECTION REPORT TO CORRECT ORIGINAL DATE AWARE. THE DATE AWARE ON THE ORIGINAL REPORT WAS 31-JAN-2018. ON REVIEW, THE FIRST COOK EMPLOYEE WAS MADE AWARE ON 22-JAN-2018
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. MFR SITE: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). A 510(K) NUMBER HAS NOT BEEN PROVIDED AS WE HAVE NO INFORMATION TO IDENTIFY THE PRODUCT. AS PER COMPLAINT FORM; ¿THE FRICTION AT THE TIP OF THE PLASTIC STENT CAUSED PSEUDOANEURYSM.¿ ADDITIONAL INFORMATION 22 JANUARY 2018; ¿WHILE PERFORMING A LITERATURE SEARCH I FOUND A CASE REPORT THAT DESCRIBES A HEPATIC ARTERY PSEUDOANEURYSM FOLLOWING THE PLACEMENT OF TWO COOK PLASTIC BILIARY STENTS (ZIMMON AND COTTON-LEUNG). THE STENTS WERE NOT USED IN ACCORDANCE WITH THE INTENDED USE (TREATMENT OF BILIARY OBSTRUCTION), BUT APPARENTLY WERE USED FOR BILE LEAK AT AN ANASTOMOSIS SITE FOLLOWING COMPLICATIONS RELATED TO A LIVER TRANSPLANT PROCEDURE.¿ LAB EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED TO CIRL FOR EVALUATION. CLINICAL INPUT: "HEPATIC OR INTRAHEPATIC ARTERY PSEUDOANEURYSM (PA) CAUSED DIRECTLY BY A PLASTIC BILIARY STENT IS RARE AND HAS ONLY BEEN DESCRIBED IN CASE REPORTS. HEPATIC ARTERY PA INDUCED BY A PLASTIC BILIARY STENT IS EXTREMELY RARE AND ONLY TWO CASES WERE REPORTED FOLLOWING LIVING-DONOR LIVE TRANSPLANTATION (LT) UP TO 2017. HEPATIC ARTERY PSEUDOANEURYSM IS A RARE BUT SERIOUS COMPLICATION FOLLOWING LIVER TRANSPLANTATION WHICH COULD LEAD TO LIFE-THREATENING HAEMORRHAGE AND SOMETIMES DEATH." 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 THE PSEUDOANEURYSM OCCURRED AS A RESULT OF THE USER PLACING THE STENT IN A LOCATION WHICH CONTRADICTS THE INTENDED USE SECTION OF THE IFU. THIS IS CONSIDERED ¿OFF- LABEL USE¿. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0045-6, THE USER IS 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¿. AS PER THE INTENDED USE SECTION OF THE IFU; "THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS." FQC/ PRD REVIEW: PRIOR TO DISTRIBUTION, ALL COTTON- LEUNG DEVICES ARE SUBJECTED TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. DOCUMENT REVIEW: AS THE LOT NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO PERFORM A DOCUMENT REVIEW. SUMMARY: THIS COMPLAINT IS CONFIRMED AS ¿OFF- LABEL USE¿. 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. MFR SITE: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). A 510(K) NUMBER HAS NOT BEEN PROVIDED AS WE HAVE NO INFORMATION TO IDENTIFY THE PRODUCT. AS PER COMPLAINT FORM; ¿THE FRICTION AT THE TIP OF THE PLASTIC STENT CAUSED PSEUDOANEURYSM.¿ ADDITIONAL INFORMATION 22 JANUARY 2018; ¿WHILE PERFORMING A LITERATURE SEARCH I FOUND A CASE REPORT THAT DESCRIBES A HEPATIC ARTERY PSEUDOANEURYSM FOLLOWING THE PLACEMENT OF TWO COOK PLASTIC BILIARY STENTS (ZIMMON AND COTTON-LEUNG). THE STENTS WERE NOT USED IN ACCORDANCE WITH THE INTENDED USE (TREATMENT OF BILIARY OBSTRUCTION), BUT APPARENTLY WERE USED FOR BILE LEAK AT AN ANASTOMOSIS SITE FOLLOWING COMPLICATIONS RELATED TO A LIVER TRANSPLANT PROCEDURE.¿ LAB EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED TO CIRL FOR EVALUATION. CLINICAL INPUT: "HEPATIC OR INTRAHEPATIC ARTERY PSEUDOANEURYSM (PA) CAUSED DIRECTLY BY A PLASTIC BILIARY STENT IS RARE AND HAS ONLY BEEN DESCRIBED IN CASE REPORTS. HEPATIC ARTERY PA INDUCED BY A PLASTIC BILIARY STENT IS EXTREMELY RARE AND ONLY TWO CASES WERE REPORTED FOLLOWING LIVING-DONOR LIVE TRANSPLANTATION (LT) UP TO 2017. HEPATIC ARTERY PSEUDOANEURYSM IS A RARE BUT SERIOUS COMPLICATION FOLLOWING LIVER TRANSPLANTATION WHICH COULD LEAD TO LIFE-THREATENING HAEMORRHAGE AND SOMETIMES DEATH." 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 THE PSEUDOANEURYSM OCCURRED AS A RESULT OF THE USER PLACING THE STENT IN A LOCATION WHICH CONTRADICTS THE INTENDED USE SECTION OF THE IFU. THIS IS CONSIDERED ¿OFF- LABEL USE¿. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0045-6, THE USER IS 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¿. AS PER THE INTENDED USE SECTION OF THE IFU; "THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS." FQC/ PRD REVIEW: PRIOR TO DISTRIBUTION, ALL COTTON- LEUNG DEVICES ARE SUBJECTED TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. DOCUMENT REVIEW: AS THE LOT NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO PERFORM A DOCUMENT REVIEW. SUMMARY: THIS COMPLAINT IS CONFIRMED AS ¿OFF- LABEL USE¿. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DR. (B)(6) INTENSION FOR WRITING THE REPORT WAS NOT TO COMPLAIN. HIS PURPOSE WAS TO REPORT ABOUT THE POSSIBLE OCCURRENCE OF PSEUDOANEURYSM AFTER THE INSERTION OF A PLASTIC STENT AFTER LT SURGERY. HE SAID IT CAN OCCUR WITH ANY PRODUCT FROM A DIFFERENT COMPANY. THE PATIENT WHO RECEIVED THE SURGERY IS RECOVERING WELL. TO MAKE IT CLEAR, AGAIN, HIS INTENTION WAS NOT TO COMPLAIN ABOUT THE PRODUCT BUT RATHER REPORT ON THE INSTANCES OF SUCH OCCURENCES IN LT SURGERY. THIS IS FOR THE COTTON-LEUNG STENT.
THIS REPORT IS BEING SUBMITTED AS A CORRECTION REPORT TO CORRECT ORIGINAL DATE AWARE REPORTED. THE DATE AWARE ON THE ORIGINAL REPORT WAS 31-JAN-2018. ON REVIEW, THE FIRST COOK EMPLOYEE WAS MADE AWARE ON 22-JAN-2018. DR.(B)(6) INTENSION FOR WRITING THE REPORT WAS NOT TO COMPLAIN. HIS PURPOSE WAS TO REPORT ABOUT THE POSSIBLE OCCURRENCE OF PSEUDOANEURYSM AFTER THE INSERTION OF A PLASTIC STENT AFTER LT SURGERY. HE SAID IT CAN OCCUR WITH ANY PRODUCT FROM A DIFFERENT COMPANY. THE PATIENT WHO RECEIVED THE SURGERY IS RECOVERING WELL. TO MAKE IT CLEAR, AGAIN, HIS INTENTION WAS NOT TO COMPLAIN ABOUT THE PRODUCT BUT RATHER REPORT ON THE INSTANCES OF SUCH OCCURENCES IN LT SURGERY. THIS IS FOR THE COTTON-LEUNG STENT.
DR.(B)(6) INTENSION FOR WRITING THE REPORT WAS NOT TO COMPLAIN. HIS PURPOSE WAS TO REPORT ABOUT THE POSSIBLE OCCURRENCE OF PSEUDOANEURYSM AFTER THE INSERTION OF A PLASTIC STENT AFTER LT SURGERY. HE SAID IT CAN OCCUR WITH ANY PRODUCT FROM A DIFFERENT COMPANY. THE PATIENT WHO RECEIVED THE SURGERY IS RECOVERING WELL. TO MAKE IT CLEAR, AGAIN, HIS INTENTION WAS NOT TO COMPLAIN ABOUT THE PRODUCT BUT RATHER REPORT ON THE INSTANCES OF SUCH OCCURENCES IN LT SURGERY. THIS IS FOR THE COTTON-LEUNG STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145741 | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Required Intervention |