NASAL PANCREATIC DRAINAGE SET
Report
- Report Number
- 3001845648-2022-00731
- Event Type
- Malfunction
- Date Received
- October 25, 2022
- Date of Event
- September 27, 2022
- Report Date
- January 10, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/510(K) # K171623. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K171623 DEVICE EVALUATION THE NPDS-5 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL NPDS-5 DEVICES ARE SUBJECT TO VISUAL 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 INSTRUCTIONS FOR USE (IFU0107) STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER¿. IT SHOULD BE NOTED THAT THE JAPANESE INSERT C-ES1406Y04 STATES THE FOLLOWING: "THIS DEVICE IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY OR PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER." THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE NPDS-5 TUBES WERE PLACED TO AVOID EXPOSURE TO BILE AND PANCREATIC JUICE, ESPECIALLY FOR LESIONS LOCATED AROUND VATER¿S PAPILLA. AS PER THE IFU, THE DEVICE IS INTENDED TO BE USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
(B)(4), MANAGEMENT OF PERFORATION RELATED TO ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL DUODENAL EPITHELIAL TUMORS. THIS RETROSPECTIVE CASE SERIES WAS CONDUCTED IN (B)(4) HOSPITAL. WE IDENTIFIED CONSECUTIVE PATIENTS WITH SDETS WHO UNDERWENT ESD FROM JULY 2010 TO DECEMBER 2018. OUR DATABASE INCLUDED ALL PATIENTS WHO UNDERWENT ENDOSCOPIC TREATMENT FOR DUODENAL LESIONS, AND PATIENTS HAVE BEEN REGISTERED PROSPECTIVELY SINCE (B)(6) 2017. ENBPD PROCEDURE: ENBPD WAS CONSIDERED WHEN COMPLETE CLOSURE OF THE POST-ESD MUCOSAL DEFECT WAS IMPOSSIBLE. THE ENBPD PROCEDURE WAS MAINLY PERFORMED USING A SIDE VIEWING ENDOSCOPE (TJF-260V; OLYMPUS MEDICAL SYSTEMS). THE SIDE-VIEWING ENDOSCOPE WAS CAREFULLY IN-SERTED TO AVOID INJURY TO THE DUODENAL WALL, ESPECIALLY WHEN ADVANCING THROUGH THE SUPERIOR DUODENAL ANGLE AND STRETCHING THE ENDOSCOPE. IN PATIENTS WHO UNDERWENT SELECTIVE CHOLANGIOGRAPHY AND PANCREATOGRAPHY, A CATHETER (ERCP-KATHETER, 0120211; (B)(6)) WAS THEN ADVANCED INTO THE COMMON BILE DUCT AND MAIN PANCREATIC DUCT WITH A .025-INCH HYDROPHILIC GUIDEWIRE (VISIGLIDE 2; OLYMPUS MEDICAL SYSTEMS). IF EACH DEEP CANNULATION WAS DIFFICULT, ANOTHER .025-INCH HYDROPHILIC GUIDE WIRE (NAVIPRO; BOSTON SCIENTIFIC, NATICK, MASS, USA) WAS APPLIED. FINALLY, A 5F PIGTAIL CATHETER (QUICKPLACE V ENBD, PBD-V813W-05; OLYMPUS MEDICAL SYSTEMS) WAS INSERTED INTO THE COMMON BILE DUCT FOR ENDOSCOPIC NASOBILIARY DRAINAGE, AND A 5F STRAIGHT CATHETER (NASAL PANCREATIC DRAINAGE SET, G21466; (B)(6)) WAS INSERTED INTO THE MAIN PANCREATIC DUCT FOR ENDOSCOPIC NASOPANCREATIC DRAINAGE. THE ENDOSCOPIC NASOBILIARY DRAINAGE AND ENDOSCOPIC NASOPANCREATIC DRAINAGE TUBES WERE ADVANCED TOGETHER AND LEFT AT A SUITABLE POSITION. DETAILS OF PATIENTS WITH INCOMPLETE CLOSURE OF INTRAOPERATIVE PERFORATION BY DUODENAL ESD: TABLE 2 SHOWS THE DETAILS OF EACH PATIENT WITHOUT COMPLETE CLOSURE OF THE PERFORATION. OF THESE 19 PATIENTS, 3 IN WHOM THE LESIONS WERE LOCATED ON THE DUODENAL BULB HAD A GOOD CLINICAL COURSE (SHORT HOSPITAL STAY AND NO NEED FOR ADDITIONAL INTERVENTIONS OR INSERTION OF AN ENBPD TUBE). OF THE 16 PATIENTS IN WHOM THE LESIONS WERE LOCATED DISTAL TO THE SUPERIOR DUODENAL ANGLE, 8 UNDERWENT ENBPD TUBE INSERTION. THESE PATIENTS REQUIRED NO ADDITIONAL INTERVENTIONS AND EXPERIENCED NO ADVERSE EVENTS RELATED TO ERCP, SUCH AS POST-ERCP PANCREATITIS. FEATURES OF PATIENTS WITH DELAYED PERFORATION AFTER DUODENAL ESD: WE IDENTIFIED 4 PATIENTS WITH DELAYED PERFORATION IN THE STUDY POPULATION. THE DETAILS OF EACH PATIENT ARE PRESENTED IN TABLE 3. DELAYED PERFORATION WAS RECOGNIZED 8 TO 33 HOURS AFTER ESD. ALL LESIONS WERE LOCATED AT THE DESCENDING PART OF THE DUODENUM, AND VATER¿S PAPILLA WAS INVOLVED IN 1 PATIENT. AN ENBPD TUBE WAS INSERTED IN 2 PATIENTS (FIG. 4), WHEREAS 1 OTHER PATIENT WITHOUT ENBPD TUBE INSERTION DEVELOPED AN EXTENDED ABDOMINAL ABSCESS REQUIRING PANCREATODUODENECTOMY. THIS FILE CAPTURES THE OFF-LABEL USAGE OF NPDS-5 IN 10 PATIENTS (8 PATIENTS WITH INCOMPLETE CLOSURE OF INTRAOPERATIVE PERFORATION BY DUODENAL ESD + 2 PATIENTS WITH DELAYED PERFORATION AFTER DUODENAL ESD). THE OFF-LABEL USE BEING PLACEMENT OF NPDS-5 TUBE TO AVOID EXPOSURE TO BILE AND PANCREATIC JUICE, ESPECIALLY FOR LESIONS LOCATED AROUND VATER¿S PAPILLA. NO ADVERSE EFFECTS REPORTED AS OCCURRING.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE (B)(6)-2023
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2920953 | NASAL PANCREATIC DRAINAGE SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |