ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2018-00592
- Event Type
- Malfunction
- Date Received
- December 17, 2018
- Date of Event
- November 19, 2018
- Report Date
- January 15, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002506203
- PMA / PMN Number
- K020788
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
510 (K) NUMBER: K020788. 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: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510 (K) NUMBER: K020788. 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). DEVICE EVALUATION THE ZILBS-635-8-6 DEVICE OF LOT NUMBER C1375651 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 13DEC2018. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE FLEXOR WAS SEPARATED. DOCUMENT REVIEW A REVIEW OF INCOMING QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL ZILBS DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER. IFU REVIEW THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. DOING SO COULD RESULT IN DIFFICULTY OR INABILITY TO REMOVE THE DELIVERY SYSTEM. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO INSUFFICIENT STRENGTH OF FLEXOR AND DIFFICULT PATIENT ANATOMY. DIFFICULT PATIENT ANATOMY COULD HAVE CAUSED OR CONTRIBUTED TO RESISTANCE DURING ADVANCEMENT. IT IS POSSIBLE THAT THE RESISTANCE COMBINED WITH INSUFFICIENT STRENGTH OF FLEXOR CAUSED OR CONTRIBUTE TO THE OUTER SHEATH (FLEXOR) TO SEPARATE FROM THE HANDLE. DEPLOYING THROUGH THE WALL OF A PREVIOUSLY PLACED STENT MAY ALSO HAVE CONTRIBUTED TO THE RESISTANCE WHICH LEAD TO THE OUTER SHEATH (FLEXOR) TO SEPARATE FROM THE HANDLE. IT MAY BE NOTED THAT A PROJECT IRE0108 HAS BEEN COMPLETED AND ADDRESSES THE ISSUE OF OUTER SHEATH SEPARATION FROM THE HANDLE. (ZILBS). SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE FLEXOR WAS SEPARATED FROM THE HANDLE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510 (K) NUMBER: K020788. 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.
BILIARY STENT PLACEMENT WAS PERFORMED FOR THE PATIENT WHO HAS HEPATIC PORTAL REGION CANCER. THE SHEATH SEPARATED FROM THE HANDLE. THEREFORE, THE USER HELD AND PULLED THE SHEATH TO DEPLOY THE STENT.
BILIARY STENT PLACEMENT WAS PERFORMED FOR THE PATIENT WHO HAS HEPATIC PORTAL REGION CANCER. THE SHEATH SEPARATED FROM THE HANDLE. THEREFORE, THE USER HELD AND PULLED THE SHEATH TO DEPLOY THE STENT.
BILIARY STENT PLACEMENT WAS PERFORMED FOR THE PATIENT WHO HAS HEPATIC PORTAL REGION CANCER. THE SHEATH SEPARATED FROM THE HANDLE. THEREFORE, THE USER HELD AND PULLED THE SHEATH TO DEPLOY THE STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1008275 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G50620 | C1375651 | 10827002506203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |