EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
Report
- Report Number
- 3001845648-2018-00121
- Event Type
- Malfunction
- Date Received
- March 13, 2018
- Date of Event
- January 30, 2018
- Report Date
- April 11, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002231297
- PMA / PMN Number
- K121430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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)(6), COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD, P.O BOX 4195, BLOOMINGTON, INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). REPORT IS BEING SUBMITTED TO UPDATE WITH ADDITIONAL INFORMATION: A QUERY WAS SENT TO THE COOK REPRESENTATIVE TO DETERMINE WHEN THE KINKS OCCURRED. THE FOLLOWING WAS RECEIVED: ¿THE PROBLEM WAS ONLY THAT THEY COULDN¿T GET THROUGH THE STENT WITH THE WIRE! THE KINK HAPPENED AFTER THE PROCEDURE, PROBABLY BECAUSE THEY JUST THROUGHT THE STENT AWAY¿ H3 OTHER TEXT : 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). REPORT IS BEING SUBMITTED TO UPDATE WITH ADDITIONAL INFORMATION: A QUERY WAS SENT TO THE COOK REPRESENTATIVE TO DETERMINE WHEN THE KINKS OCCURRED. THE FOLLOWING WAS RECEIVED: ¿THE PROBLEM WAS ONLY THAT THEY COULDN¿T GET THROUGH THE STENT WITH THE WIRE! THE KINK HAPPENED AFTER THE PROCEDURE, PROBABLY BECAUSE THEY JUST THROUGHT THE STENT AWAY.¿
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). PROBLEM STATEMENT: IT IS IMPOSSIBLE TO GET THE WIRE GUIDE OUT OF THE CATHETER BECAUSE THERE IS NO HOLE. DEVICE EVALUATION: THE EVO-10-11-8-B DEVICE OF LOT NUMBER C1410309 WAS RETURNED TO COOK IRELAND AND EVALUATION ON THE 14-FEB-2018. LAB EVALUATION: UPON EVALUATION OF THE RETURNED DEVICE, THERE WAS NO STENT EXPOSURE. THE LOCKWIRE WAS RETURNED IN PLACE. THE RED SHUTTLE DEPLOYMENT MARKER WAS AT THE FRONT OF THE HANDLE. THE DEVICE WAS WIRED SUCCESSFULLY WITH A 0.035¿ WIREGUIDE, WITH A SLIGHT CURVE APPLIED TO THE FLEXOR. THERE WERE SEVERAL KINKS NOTED ON THE FLEXOR AT 63CM, 107.5CM AND 132CM. THESE WERE MOST LIKELY DUE TO TRANSPORT ON THE RETURN OF THE DEVICE OR USER HANDLING FROM FORCE APPLIED ON INSERTION INTO THE SCOPE. DUE TO THE LOCATION OF THE KINKS ON THE FLEXOR, THESE WOULD HAVE HAD NO IMPACT ON THE REPORTED FAILURE OF INABILITY TO WIRE THE DEVICE BECAUSE THERE WAS NO "HOLE". THE REPORTED COMPLAINT IS NOT CONFIRMED AS THE FAILURE COULD NOT BE VERIFIED IN THE LABORATORY. THE COMPLAINT DESCRIPTION WAS THERE WAS NO HOLE IN THE CATHETER TO ALLOW THE WIREGUIDE TO EXIT. THIS WAS NOT CONFIRMED IN THE LAB AS THE DEVICE WIRED SUCCESSFULLY THROUGH THE "HOLE" (ZIP PORT AREA). HOWEVER THERE WERE SEVERAL KINKS NOTED ON THE FLEXOR, FLEXOR KINKING IS CONFIRMED. A QUERY HAS BEEN SENT TO THE COOK REPRESENTATIVE TO DETERMINE WHEN THE KINKS OCCURRED, ONCE A RESPONSE IS RECEIVED THE INVESTIGATION WILL BE UPDATED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL EVO-10-11-8-B 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. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-10-11-8-B DEVICE OF LOT NUMBER C1410309 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1410309; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1410309. IFU REVIEW: AS PER THE INSTRUCTIONS FOR USE, 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". ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. SUMMARY: THE REPORTED COMPLAINT IS NOT CONFIRMED AS THE FAILURE COULD NOT BE VERIFIED IN THE LABORATORY. THE COMPLAINT DESCRIPTION WAS THERE WAS NO HOLE IN THE CATHETER TO ALLOW THE WIREGUIDE TO EXIT. THIS WAS NOT CONFIRMED IN THE LAB AS THE DEVICE WIRED SUCCESSFULLY THROUGH THE "HOLE" (ZIP PORT AREA). HOWEVER THERE WERE SEVERAL KINKS NOTED ON THE FLEXOR, FLEXOR KINKING IS CONFIRMED. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THIS EVENT OCCURRED PRIOR TO PATIENT CONTACT. 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 PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.
REPORT IS BEING SUBMITTED TO UPDATE WITH ADDITIONAL INFORMATION. IT IS IMPOSSIBLE TO GET THE WIRE GUIDE OUT OF THE CATHETER BECAUSE THERE IS NO HOLE .
REPORT IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED". IT IS IMPOSSIBLE TO GET THE WIRE GUIDE OUT OF THE CATHETER BECAUSE THERE IS NO HOLE .
INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED". IT IS IMPOSSIBLE TO GET THE WIRE GUIDE OUT OF THE CATHETER BECAUSE THERE IS NO HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176587 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | G23129 | 10827002231297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |