GEENEN PANCREATIC STENT SET
Report
- Report Number
- 3001845648-2019-00012
- Event Type
- Injury
- Date Received
- January 10, 2019
- Date of Event
- December 6, 2018
- Report Date
- February 7, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
510 (K) NUMBER; K900923. 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; K900923. 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.
(B)(4). 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). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 1. DEVICE EVALUATION: 1 X GEPD-5-7 DEVICE OF UNKNOWN LOT NUMBER WAS RETURNED TO CIRL FOR A LAB EVALUATION. IT WAS RETURNED OPENED AND USED AND NOT IN IT¿S ORIGINAL PACKAGING. 2. LAB EVALUATION: THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN LABORATORY ON 11TH OF JANUARY 2019. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION. PART OF THE STENT WAS RETURNED BROKEN WITH BLACK MARKS. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. 3. ROOT CAUSE (POSSIBLE): 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 EXCEEDING THE RECOMMEND INDWELLING TIME. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICES INSTRUCTS THE USER NOT TO EXCEED A THREE MONTH INDWELL PERIOD. THIS STENT HAD BEEN IN PATIENT FOR GREATER THAN 10 MONTHS WHICH COULD POSSIBLY EXPLAIN THE BREAKAGE DURING STENT RETRIEVAL. REFERENCE CLINICAL REVIEWERS INPUT ¿ RE (B)(4) CLINICAL INPUT¿ ALSO PERIODICALLY EVALUATION IS RECOMMENDED WHILE A PATIENT HAS THIS DEVICE IMPLANTED, AS PER THE ADDITIONAL INFORMATION THE PATIENT DID NOT PRESENT FOR EVALUATION UNTIL THE WINTER MONTHS DUE TO WORK COMMITMENTS. 4. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE GEPD-5-7 INVOLVED IN THIS COMPLAINT COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE, IFU (IFU0055-3) WHICH ACCOMPANIES THIS DEVICE PRECAUTIONS THE END USER TO ¿THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED¿. 5. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. BASED ON THE AVAILABLE INFORMATION THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.
A 7FR STENT HAD BEEN PLACED IN THE ACCESSORY PANCREATIC DUCT OF THE PATIENT. IT'S UNKNOWN HOW LONG IT HAD BEEN PLACED. (B)(6) 2018: THE PREVIOUS ONE WAS REPLACED WITH THE GEPD-5-7. DURING THE REPLACEMENT PROCEDURE, THERE WAS NO STRONG RESISTANCE. THE PATIENT RUNS A FARMING FAR FROM THE HOSPITAL, SO VISITING HOSPITAL WAS DIFFICULT EXCEPT DURING WINTER SEASON. (B)(6) 2018: THE PATIENT VISITED THE HOSPITAL FOR DETAILED EXAMINATION FOR SUSPICIOUS PANCREATIC CANCER AND REPLACEMENT OF THE STENT. DURING REMOVAL OF THE STENT USING A SNARE (MODEL OR MANUFACTURER UNKNOWN), THE STENT BROKE AT APPROXIMATELY 1CM FROM THE PROXIMAL END. THE STENT WAS STILL VISIBLE AT THE MINOR PAPILLA, SO THE DOCTOR CAPTURED IT WITH THE SNARE AND ATTEMPTED TO REMOVE, BUT THE STENT BROKE AGAIN AT AROUND THE MIDDLE PART THAT WAS LOCATED IN THE ACCESSORY PANCREATIC DUCT. HE ATTEMPTED TO REMOVE THE REMAINED BROKEN STENT (APPROX 3CM), BUT FAILED SINCE HE COULD NOT ADVANCE A WIRE GUIDE TO THE DISTAL SIDE OF THE STENT. SO HE PLACED OTHER MANUFACTURER'S PANCREATIC STENT IN THE PROXIMAL SIDE OF THE REMAINED BROKEN STENT AND COMPLETED THE PROCEDURE. THE OTHER MANUFACTURER'S STENT WAS REMOVED LATER BECAUSE THE CONDITION OF THE PATIENT WAS STABLE. THE BROKEN STENT "HAS STILL REMAINED" IN THE PATIENT AND THE PATIENT IS FOLLOWED-UP.
A 7FR STENT HAD BEEN PLACED IN THE ACCESSORY PANCREATIC DUCT OF THE PATIENT. IT'S UNKNOWN HOW LONG IT HAD BEEN PLACED. (B)(6) 2018: THE PREVIOUS ONE WAS REPLACED WITH THE GEPD-5-7. DURING THE REPLACEMENT PROCEDURE, THERE WAS NO STRONG RESISTANCE. THE PATIENT RUNS A FARMING FAR FROM THE HOSPITAL, SO VISITING HOSPITAL WAS DIFFICULT EXCEPT DURING WINTER SEASON. (B)(6) 2018: THE PATIENT VISITED THE HOSPITAL FOR DETAILED EXAMINATION FOR SUSPICIOUS PANCREATIC CANCER AND REPLACEMENT OF THE STENT. DURING REMOVAL OF THE STENT USING A SNARE (MODEL OR MANUFACTURER UNKNOWN), THE STENT BROKE AT APPROXIMATELY 1CM FROM THE PROXIMAL END. THE STENT WAS STILL VISIBLE AT THE MINOR PAPILLA, SO THE DOCTOR CAPTURED IT WITH THE SNARE AND ATTEMPTED TO REMOVE, BUT THE STENT BROKE AGAIN AT AROUND THE MIDDLE PART THAT WAS LOCATED IN THE ACCESSORY PANCREATIC DUCT. HE ATTEMPTED TO REMOVE THE REMAINED BROKEN STENT (APPROX 3CM), BUT FAILED SINCE HE COULD NOT ADVANCE A WIRE GUIDE TO THE DISTAL SIDE OF THE STENT. SO HE PLACED OTHER MANUFACTURER'S PANCREATIC STENT IN THE PROXIMAL SIDE OF THE REMAINED BROKEN STENT AND COMPLETED THE PROCEDURE. THE OTHER MANUFACTURER'S STENT WAS REMOVED LATER BECAUSE THE CONDITION OF THE PATIENT WAS STABLE. THE BROKEN STENT IS STILL REMAINED IN THE PATIENT AND THE PATIENT IS FOLLOWED-UP.
A 7FR STENT HAD BEEN PLACED IN THE ACCESSORY PANCREATIC DUCT OF THE PATIENT. IT'S UNKNOWN HOW LONG IT HAD BEEN PLACED. (B)(6) 2018: THE PREVIOUS ONE WAS REPLACED WITH THE GEPD-5-7. DURING THE REPLACEMENT PROCEDURE, THERE WAS NO STRONG RESISTANCE. THE PATIENT RUNS A FARMING FAR FROM THE HOSPITAL, SO VISITING HOSPITAL WAS DIFFICULT EXCEPT DURING WINTER SEASON. (B)(6) 2018: THE PATIENT VISITED THE HOSPITAL FOR DETAILED EXAMINATION FOR SUSPICIOUS PANCREATIC CANCER AND REPLACEMENT OF THE STENT. DURING REMOVAL OF THE STENT USING A SNARE (MODEL OR MANUFACTURER UNKNOWN), THE STENT BROKE AT APPROXIMATELY 1CM FROM THE PROXIMAL END. THE STENT WAS STILL VISIBLE AT THE MINOR PAPILLA, SO THE DOCTOR CAPTURED IT WITH THE SNARE AND ATTEMPTED TO REMOVE, BUT THE STENT BROKE AGAIN AT AROUND THE MIDDLE PART THAT WAS LOCATED IN THE ACCESSORY PANCREATIC DUCT. HE ATTEMPTED TO REMOVE THE REMAINED BROKEN STENT (APPROX 3CM), BUT FAILED SINCE HE COULD NOT ADVANCE A WIRE GUIDE TO THE DISTAL SIDE OF THE STENT. SO HE PLACED OTHER MANUFACTURER'S PANCREATIC STENT IN THE PROXIMAL SIDE OF THE REMAINED BROKEN STENT AND COMPLETED THE PROCEDURE. THE OTHER MANUFACTURER'S STENT WAS REMOVED LATER BECAUSE THE CONDITION OF THE PATIENT WAS STABLE. THE BROKEN STENT IS STILL REMAINED IN THE PATIENT AND THE PATIENT IS FOLLOWED-UP. FDA MDR REPORTING REQUIRED - REPORTING REQUIRED BASED ON THE REQUIREMENT FOR A SURGICAL INTERVENTION AS THE BROKEN STENT HAD TO BE RETRIEVED AND AN ADDITIONAL STENT WAS PLACED OVER THE BROKEN PART OF THE STENT THAT COULD NOT BE RETRIEVED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING. A MALFUNCTION PRECEDENCE ALREADY EXISTS FOR THIS MALFUNCTION "STENT FRACTURE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27960 | GEENEN PANCREATIC STENT SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |