UNKNOWN
Report
- Report Number
- 3001845648-2021-00448
- Event Type
- Malfunction
- Date Received
- June 9, 2021
- Date of Event
- May 21, 2017
- Report Date
- September 28, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
EXACT RPN CANNOT BE CONFIRMED, POTENTIAL 510(K) NUMBER IS K900923 OR K990130. DEVICE EVALUATION: THE GEENEN/ZIMMON PANCREATIC STENTS OF UNKNOWN LOT NUMBER AND RPN INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE, "ENDOSCOPIC TREATMENT OF MULTILOCULAR WALLED-OFF PANCREATIC NECROSIS WITH THE MULTIPLE TRANSLUMINAL GATEWAY TECHNIQUE" COMPLAINT FILES (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. (B)(4) (REPORT REFERENCE NUMBER 3001845648-2021-00444) COVERS 1 CASE OFF-LABEL USE WITH THE CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE. (RPN: CST-10). (B)(4) (REPORT REFERENCE NUMBER 3001845648-2021-00445) COVERS 1 CASE OF OFF-LABEL USE WITH THE NASAL PANCREATIC DRAINAGE SET. (RPN: NPDS-7). (B)(4) (REPORT REFERENCE NUMBER 3001845648-2021-00448) COVERS 6 CASES OF OFF-LABEL USE WITH PANCREATIC STENTS. (RPN: UNKNOWN). AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL PANCREATIC STENT 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. IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU0055-4) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ A POSSIBLE USER ERROR OF EXCEEDING THE MAXIMUM 3 MONTH INDWELL PERIOD IS ALSO NOTED HERE AS THE STENTS WERE REMOVED "6 MONTHS AFTER THE END OF THE ACTIVE DRAINAGE". THIS WOULD BE CONSIDERED SECONDARY TO THE OFF-LABEL USE OF THE DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. ONE PATIENT, A 66 YEAR OLD MALE WAS FOUND TO HAVE THREE WELL-DEFINED, PANCREATIC FLUID COLLECTIONS WITH NECROTIC CONTENTS. TWO PANCREATIC STENTS (WILSON-COOK, IRELAND) WERE INSERTED INTO THE FISTULA AND USED IN WOPN (WALLED-OFF PANCREATIC NECROSIS). THIS IS REGARDED AS OFF-LABEL USE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE STENTS WERE REMOVED AFTER DUE TO THE CLINICAL CONDITION AND RESULTS OF RADIOLOGICAL EXAMINATION. THERE WAS NO LEAK INTO THE PERIPANCREATIC AREA OBSERVED AND AFTER 2 YEARS OF OBSERVATION THE PATIENT WAS IN GOOD CONDITION WITH NO NEW RECURRENCE OF COLLECTIONS OBSERVED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
EXACT RPN CANNOT BE CONFIRMED, POTENTIAL 510(K) NUMBER IS K900923 OR K990130. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
EXACT RPN CANNOT BE CONFIRMED, POTENTIAL 510(K) NUMBER IS K900923 OR K990130. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
EVENT DESCRIPTION UPDATED ON REVIEW OF THE FILE 23-JUN-2021- SUPPLEMENT FDA REPORT BEING SUBMITTED. UPDATED EVENT DESCRIPTION BELOW JAGIELSKI ET AL 2017 ¿ENDOSCOPIC TREATMENT OF MULTILOCULAR WALLED-OFF PANCREATIC NECROSIS WITH THE MULTIPLE TRANSLUMINAL GATEWAY TECHNIQUE¿. A 66-YEAR-OLD MALE PATIENT WAS ADMITTED TO THE OUR DEPARTMENT IN (B)(6) 2014 WITH PAIN OF THE ABDOMEN ACCOMPANIED WITH NAUSEA. THE PATIENT WAS ADMITTED TO OUR DEPARTMENT FOR AN EMERGENCY PROCEDURE AGAIN IN (B)(6) 2014 DUE TO SYMPTOMS OF INFECTED WALLED-OFF PANCREATIC NECROSIS. THE PRESENCE OF THREE WELL-DEFINED, PANCREATIC FLUID COLLECTIONS WITH NECROTIC CONTENTS WAS REVEALED IN CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CECT) OF THE ABDOMEN PERFORMED AT ADMISSION. A STOMA BETWEEN THE GASTRIC LUMEN AND THE COLLECTION POSITIONED AT THE BORDER OF THE BODY AND TAIL OF THE PANCREAS WAS CREATED USING A CYSTOTOME (CYSTOTOME CST-10, WILSON-COOK, IRELAND) AND UNDER CONTROL OF ENDOSCOPIC ULTRASONOGRAPHY (EUS) (PENTAX EG3870UTK, JAPAN). THE GASTROCYSTOSTOMY WAS WIDENED USING A HIGH-PRESSURE BALLOON (BOSTON SCIENTIFIC, USA) TO THE DIAMETER OF 15 MM (PHOTO 2). THEREAFTER TWO 7 FR ENDOPROSTHESES (WILSON-COOK, IRELAND) AND A 7 FR NASAL DRAIN (WILSON-COOK, IRELAND) WERE GUIDED THROUGH THE STOMA INTO THE LUMEN OF THE COLLECTION FOR IRRIGATION PURPOSES. THE SECOND ENDOSCOPIC PROCEDURE WAS PERFORMED AFTER 7 DAYS OF ACTIVE DRAINAGE. CONTRAST APPLIED THROUGH THE NASAL DRAIN DEMONSTRATED PARTIAL REGRESSION OF THE DRAINED NECROTIC COLLECTION. THE FACT THAT THE REMAINING TWO WALLED-OFF COLLECTIONS HELD ON DESPITE THE USE OF DRAINAGE WAS REVEALED ON THE ENDOSONOGRAPHY IMAGE. THE NEXT GASTROPANCREATIC FISTULA WAS PERFORMED DURING THE SAME PROCEDURE UNDER EUS CONTROL IN THE ANTRUM OF THE STOMACH. THEREAFTER TWO 7 FR ENDOPROSTHESES WERE GUIDED THROUGH THE FISTULA. REGRESSION OF NECROTIC COLLECTIONS WAS REVEALED IN CECT OF THE ABDOMEN, WHICH WAS PERFORMED AFTER TWO WEEKS. THE NEXT (THIRD) ENDOSCOPIC PROCEDURE WAS PERFORMED AFTER 17 DAYS OF ACTIVE DRAINAGE. TWO PANCREATIC STENTS (WILSON-COOK, IRELAND) WERE INSERTED TRANSPAPILLARY. LEAVING FOUR TRANSMURAL ENDOPROSTHESES AND TWO TRANSPAPILLARY PANCREATIC STENTS. DURING THE PERFORMED ENDOSCOPIC EXAMINATION IT WAS DECIDED TO REMOVE TRANSMURAL STENTS, DUE TO THE CLINICAL CONDITION AND THE RESULTS OF RADIOLOGICAL EXAMINATION. THE PREVIOUSLY GUIDED TRANSPAPILLARY PANCREATIC ENDOPROSTHESES WERE ALSO REMOVED. WHAT IS MORE, THE MAIN PANCREATIC DUCT WAS CONTRASTED AND NO LEAK INTO THE PERIPANCREATIC AREA WAS OBSERVED. AFTER 2 YEARS OF OBSERVATION THE PATIENT IS SAID TO BE IN GOOD GENERAL CONDITION, WITHOUT ANY SYMPTOMS. NO NEW RECURRENCE OF COLLECTIONS WAS OBSERVED LATER ON, DURING THE NEXT IMAGING EXAMINATIONS. THIS FILE IS BEING CREATED TO CAPTURE THE OFF LABEL USE OF PLASTIC STENTS AS THERE WERE PLACED IN THE FISTULA AND BEING USED IN WOPN. USER ERROR IS ALSO RELATED TO THIS FILE AS THE STENTS WERE NOT REMOVED FOR 6 MONTHS WHICH EXCEEDS THE RECOMMENDED INDWELL TIME.
JAGIELSKI ET AL 2017 ¿ENDOSCOPIC TREATMENT OF MULTILOCULAR WALLED-OFF PANCREATIC NECROSIS WITH THE MULTIPLE TRANSLUMINAL GATEWAY TECHNIQUE¿ A (B)(6) YEAR-OLD MALE PATIENT WAS ADMITTED TO THE OUR DEPARTMENT IN (B)(6) 2014 WITH PAIN OF THE ABDOMEN ACCOMPANIED WITH NAUSEA. THE PATIENT WAS ADMITTED TO OUR DEPARTMENT FOR AN EMERGENCY PROCEDURE AGAIN IN (B)(6) 2014 DUE TO SYMPTOMS OF INFECTED WALLED-OFF PANCREATIC NECROSIS. THE PRESENCE OF THREE WELL-DEFINED, PANCREATIC FLUID COLLECTIONS WITH NECROTIC CONTENTS WAS REVEALED IN CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CECT) OF THE ABDOMEN PERFORMED AT ADMISSION A STOMA BETWEEN THE GASTRIC LUMEN AND THE COLLECTION POSITIONED AT THE BORDER OF THE BODY AND TAIL OF THE PANCREAS WAS CREATED USING A CYSTOTOME (CYSTOTOME CST-10, WILSON-COOK, IRELAND) AND UNDER CONTROL OF ENDOSCOPIC ULTRASONOGRAPHY (EUS) (PENTAX EG3870UTK, JAPAN). THE GASTROCYSTOSTOMY WAS WIDENED USING A HIGH-PRESSURE BALLOON (BOSTON SCIENTIFIC, USA) TO THE DIAMETER OF 15 MM (PHOTO 2). THEREAFTER TWO 7 FR ENDOPROSTHESES (WILSON-COOK, IRELAND) AND A 7 FR NASAL DRAIN (WILSON-COOK, IRELAND) WERE GUIDED THROUGH THE STOMA INTO THE LUMEN OF THE COLLECTION FOR IRRIGATION PURPOSES THE SECOND ENDOSCOPIC PROCEDURE WAS PERFORMED AFTER 7 DAYS OF ACTIVE DRAINAGE. CONTRAST APPLIED THROUGH THE NASAL DRAIN DEMONSTRATED PARTIAL REGRESSION OF THE DRAINED NECROTIC COLLECTION. THE FACT THAT THE REMAINING TWO WALLED-OFF COLLECTIONS HELD ON DESPITE THE USE OF DRAINAGE WAS REVEALED ON THE ENDOSONOGRAPHY IMAGE. THE NEXT GASTROPANCREATIC FISTULA WAS PERFORMED DURING THE SAME PROCEDURE UNDER EUS CONTROL IN THE ANTRUM OF THE STOMACH. THEREAFTER TWO 7 FR ENDOPROSTHESES WERE GUIDED THROUGH THE FISTULA. REGRESSION OF NECROTIC COLLECTIONS WAS REVEALED IN CECT OF THE ABDOMEN, WHICH WAS PERFORMED AFTER TWO WEEKS. THE NEXT (THIRD) ENDOSCOPIC PROCEDURE WAS PERFORMED AFTER 17 DAYS OF ACTIVE DRAINAGE. TWO PANCREATIC STENTS (WILSON-COOK, IRELAND) WERE INSERTED TRANSPAPILLARY. LEAVING FOUR TRANSMURAL ENDOPROSTHESES AND TWO TRANSPAPILLARY PANCREATIC STENTS. DURING THE PERFORMED ENDOSCOPIC EXAMINATION IT WAS DECIDED TO REMOVE TRANSMURAL STENTS, DUE TO THE CLINICAL CONDITION AND THE RESULTS OF RADIOLOGICAL EXAMINATION. THE PREVIOUSLY GUIDED TRANSPAPILLARY PANCREATIC ENDOPROSTHESES WERE ALSO REMOVED. WHAT IS MORE, THE MAIN PANCREATIC DUCT WAS CONTRASTED AND NO LEAK INTO THE PERIPANCREATIC AREA WAS OBSERVED. AFTER 2 YEARS OF OBSERVATION THE PATIENT IS SAID TO BE IN GOOD GENERAL CONDITION, WITHOUT ANY SYMPTOMS. NO NEW RECURRENCE OF COLLECTIONS WAS OBSERVED LATER ON, DURING THE NEXT IMAGING EXAMINATIONS. THIS FILE IS BEING CREATED TO CAPTURE THE OFF LABEL USE OF PLASTIC STENTS AS THERE WERE PLACED IN THE FISTULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863230 | UNKNOWN | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |