GEENEN PANCREATIC STENT
Report
- Report Number
- 3001845648-2018-00551
- Event Type
- Malfunction
- Date Received
- November 27, 2018
- Date of Event
- October 30, 2018
- Report Date
- January 16, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 00827002221079
- PMA / PMN Number
- K900923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 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.
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. DEVICE EVALUATION: 1 X GPSO-5-3 DEVICE OF LOT C1512248 WAS RETURNED TO CIRL FOR A LAB EVALUATION. IT WAS RETURNED OPENED IN IT¿S ORIGINAL PACKAGING. LAB EVALUATION: THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN LABORATORY ON 3RD OF DECEMBER 2018. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION. ALL OF THE STENT WAS THERE IN ONE PIECE, NO DEFECTS FOUND. THERE WERE NO DEFECTS OBSERVED ON THE STENT. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. ROOT CAUSE (POSSIBLE): NO DEFECT WAS IDENTIFIED WITH THE STENT. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. THE REASON GIVEN BY THE USER THAT THEY COULD NOT ADVANCE THE STENT DUE TO MISSING FLAPS ON DISTAL END WOULD NOT CAUSE ADVANCEMENT DIFFICULTIES AS THE FLAPS HAVE NO IMPACT ON HOW THE STENT ADVANCES OVER THE WIRE. HOWEVER, THE ISSUE THE USER EXPERIENCE WITH ADVANCEMENT DIFFICULTIES COULD HAVE BEEN DUE TO AN INCORRECT STENT SELECTION. THE PHYSICIAN MAY HAVE CHOSEN A STENT THAT WAS TOO SHORT FOR THE DUCT. SEE ATTACHED EMAIL FROM ENGINEERING ¿PR244596_ENGINEERING INPUT¿. DOCUMENTS REVIEW: THE INSTRUCTIONS FOR USE, IFU (IFU0055-3) WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE END USER 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¿. THE INSTRUCTIONS FOR USE, IFU (IFU0055-3) WHICH ACCOMPANIES THIS DEVICE CAUTIONS THE END USER TO ¿COMPLETE DIAGNOSTIC EVALUATION MUST BE PERFORMED, PRIOR TO USE, TO DETERMINE PROPER STENT SIZE.¿ SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.
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.
THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE". THE GPSO-5-3 COULDN'T GET IN THE PANCRATIC DUCT BECAUSE THE GPSO-5-3 DISTAL FLAP WAS BROKEN.
THE GPSO-5-3 COULDN'T GET IN THE PANCRATIC DUCT BECAUSE THE GPSO-5-3 DISTAL FLAP WAS BROKEN.
THE GPSO-5-3 COULDN'T GET IN THE PANCRATIC DUCT BECAUSE THE GPSO-5-3 DISTAL FLAP WAS BROKEN.
THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE" . THE GPSO-5-3 COULDN'T GET IN THE PANCRATIC DUCT BECAUSE THE GPSO-5-3 DISTAL FLAP WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 946197 | GEENEN PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | G22107 | C1512248 | 00827002221079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |