NASAL PANCREATIC DRAINAGE SET
Report
- Report Number
- 3001845648-2020-00673
- Event Type
- Malfunction
- Date Received
- September 29, 2020
- Date of Event
- May 14, 2020
- Report Date
- October 12, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
510(K): K171623. THE 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. LAB EVALUATION ¿ N/A 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 (IFU0107-2) STATES THE FOLLOWING: ¿INTENDED USE 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.¿ ¿CONTRAINDICATIONS CONTRAINDICATIONS INCLUDE THOSE SPECIFIC TO ERCP.¿ THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW ¿ N/A 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 DEVICE WAS USED IN PATIENT¿S WITH ALTERED ANATOMY. AS THERE IS NO INSTRUCTIONS FOR USING THESE DEVICES IN SURGICALLY ALTERED ANATOMY AND AS THE DEVICE WAS USED OUTSIDE OF ITS VALIDATED STATE, THIS IS CONSIDERED OFF-LABEL USE. IT IS ALSO KNOWN THAT THE NPDS DEVICES WERE USED WITH A NON-RECOMMENDED WIRE GUIDE DURING THE PROCEDURE. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, NPDS-5 DEVICES WERE PLACED IN 08 PATIENTS WHO EXPERIENCED NO ADVERSE EFFECTS AS A RESULT. THE DEVICES WERE ALSO PLACED USING NON-RECOMMENDED WIRE GUIDES. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED FOLLOWING A REVIEW OF LITERATURE BY THE PMS GROUP AND AN ADDITIONAL OFF-LABEL USE WAS IDENTIFIED AS THE 8 NPDS-5 DEVICES STENTS WERE PLACED IN A CREATED FISTULA RATHER THAN A DUCT. KOGURE ET AL 2020 ¿ENDOSCOPIC MANAGEMENT OF PANCREATIC DISEASES IN PATIENTS WITH SURGICALLY ALTERED ANATOMY: CLINICAL OUTCOMES OF COMBINATION OF DOUBLE-BALLOON ENDOSCOPY- AND ENDOSCOPIC ULTRASOUND-GUIDED INTERVENTIONS¿ THE CURRENT STUDY AIMED TO RETROSPECTIVELY EVALUATE THE FEASIBILITY, EFFECTIVENESS, AND SAFETY OF A COMBINATION OF DBE ASSISTED AND EUS-GUIDED PANCREATIC INTERVENTIONS IN PATIENTS WITH SURGICALLY ALTERED ANATOMY. A SINGLE-CENTER RETROSPECTIVE ANALYSIS OF PATIENTS WITH SURGICALLY ALTERED ANATOMY WHO UNDERWENT PANCREATIC INTERVENTIONS VIA SHORT DOUBLE-BALLOON ENDOSCOPE-ASSISTED ERP (DB-ERP) AND ENDOSCOPIC ULTRASONOGRAPHY- GUIDED PANCREATIC DUCT DRAINAGE (EUS-PD) BETWEEN (B)(6) 2006 AND (B)(6) 2019. SURGICALLY ALTERED ANATOMY UNDERGOING ENDOSCOPIC TREATMENT (DB-ERP, EUS-PD, OR BOTH) FOR PANCREATIC DISEASES WERE STUDIED. DB-ERP: SELECTIVE CANNULATION TO THE PANCREATIC DUCT WAS ATTEMPTED VIA A CONTRASTASSISTED OR WIRE-GUIDED METHOD USING A STRAIGHT CANNULA(0.025-INCH ERCP CATHETER; MTW ENDOSKOPIE, WESEL,GERMANY) OR A ROTATABLE SPHINCTEROTOME (TRUETOME; BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA) WITH A 0.035- OR 0.025-INCH HYDROPHILIC GUIDEWIRE (RADIFOCUS; TERUMO, TOKYO, JAPAN). IN CASES WITH SEVERE STRICTURE OR OBSTRUCTION OF THE PJ ANASTOMOSIS, A METAL-TIP CANNULA(PR-132Q; OLYMPUS) AND A 0.018-INCH HYDROPHILIC GUIDEWIRE (RADIFOCUS) WERE USED. SUBSEQUENTLY, THE GUIDEWIRE WAS REPLACED WITH A 0.025-INCH STIFF GUIDEWIRE(REVOWAVE; PIOLAX MEDICAL DEVICES, KANAGAWA, JAPAN) TO USE WIRE-GUIDED DEVICES, SUCH AS A BALLOON DILATION CATHETER, A BASKET CATHETER, AND AN EXTRACTION BALLOON CATHETER. THE DIAMETER OF THE DILATION BALLOON WAS SELECTED NOT EXCEEDING THAT OF THE PANCREATIC DUCT PROXIMAL TO THE STRICTURE. IF THE WAIST OF THE BALLOON DID NOT DISAPPEAR AND THE STRICTURE WAS CONSIDERED PERSISTENT, A 5- OR 7-FR TRANSANASTOMOTIC PANCREATIC STENT WAS INSERTED (GEENEN; COOK MEDICAL, BLOOMINGTON, IN, USA, FIG. 2). PANCREATIC STENT WAS EXCHANGED EVERY 3 MONTHS AND THE NUMBER OF STENTS WAS INCREASED, IF POSSIBLE, UNTIL THE STRICTURE RESOLUTION WAS CONFIRMED. PDSS WERE EXTRACTED USING BASKET AND EXTRACTION BALLOON CATHETERS IN A RETROGRADE MANNER FOLLOWING BALLOON DILATION OF THE ANASTOMOTIC STRICTURE OR AMPULLA.26 IN PATIENTS WITH PF, A 5-FR NASOPANCREATIC CATHETER WAS PLACED (NPDS-5; COOK MEDICAL). EUS-PD: A 0.025-INCH GUIDEWIRE (VISIGLIDE2; OLYMPUS) WAS INTRODUCED INTO THE PANCREATIC DUCT, AND IF POSSIBLE, PASSED THE STRICTURE INTO THE JEJUNUM. AFTER DILATION OF THE PANCREATICOGASTROSTOMY TRACT USING A 4-MM BALLOON CATHETER AND/OR A CAUTERY DILATOR, A 5- OR 7-FR TRANS-MURAL PANCREATIC STENT (GEENEN, COOK MEDICAL; ZIMMON, COOK MEDICAL; FLEXIMA, BOSTON SCIENTIFIC; OR THROUGH & PASS, GADELIUS MEDICAL, TOKYO, JAPAN) OR A 5- FR NASOPANCREATIC CATHETER WAS INSERTED IN AN ANTEGRADE MANNER (FIG. 3). IN PATIENTS WITH PJAS, A PANCREATIC STENT WAS PLACED ACROSS THE STRICTURE, IF POSSIBLE. PDS WAS ANTEGRADELY PUSHED OUT USING AN EXTRACTION BALLOON CATHETER. PRIOR SURGERY AND GASTROINTESTINAL RECONSTRUCTION WERE PANCREATICODUODENECTOMY (PD) WITH BILLROTH-II IN 26 (45.0%), PD WITH ROUX-EN-Y (R-Y) IN 10 (25.0%), PD WITH IMANAGA METHOD IN ONE (2.5%), AND DISTAL GASTRECTOMY WITH R-Y IN THREE (7.5%). PANCREATICOJEJUNOSTOMY ANASTOMOTIC STRICTURE WAS TREATED BY BALLOON DILATION ALONE IN 11 PATIENTS AND BALLOON DILATION WITH STENT PLACEMENT IN 18 PATIENTS. THE RATE OF STRICTURE RESOLUTION VIA PLASTIC STENT PLACEMENT WAS 33.3% (6/18) WITH A MEDIAN STENT INDWELLING TIME OF 9.6 MONTHS (IQR, 6.6¿13.1 MONTHS). STRICTURE RECURRENCE AFTER STENT REMOVAL WAS OBSERVED IN THREE PATIENTS (50%) AFTER 3.3, 7.6, AND 13.6 MONTHS FROM STENT REMOVAL, WHICH WAS MANAGED BY PLASTIC STENT PLACEMENT AGAIN. ADVERSE EVENTS WERE OBSERVED IN 12.2% (5/41) AFTER DBERP: ONE PERFORATION (MODERATE, 1) AND FOUR PANCREATITIS (MODERATE, 3; MILD, 1). IN ONE PATIENT WITH PERFORATION, PNEUMOPERITONEUM WAS OBSERVED ON FLUOROGRAPHY DURING PANCREATIC CANNULATION USING A METAL-TIP CANNULA. A 5-FR CATHETER WAS LEFT IN THE AFFERENT LIMB TO AVOID LEAKAGE OF BILE AND PANCREATIC JUICE, AND THE PATIENT REMAINED ASYMPTOMATIC WITHOUT SUBSEQUENT PERITONITIS. TOGETHER WITH SEVEN SALVAGE PROCEDURES, THE ADVERSE EVENT RATE OF EUS-PD WAS 55.6% (5/9): THREE PANCREATIC LEAKAGE (MODERATE, 2; MILD, 1) AND TWO ABDOMINAL PAIN (MILD, 2). RPN: NPDS-5. THIS FILE IS BEING CREATED TO CAPTURE THE OFF LABEL USE OF THE 8 NPDS-5 DEVICES AS THEY WERE PLACED IN SURGICALLY ALTERED ANATOMY. USER ERROR IS ALSO RELATED TO THIS FILE AS INCORRECT WIRE GUIDE WAS USED. AN ADDITIONAL COMPLAINT WAS CREATED TO CAPTURE OFF LABEL RELATED TO THE REMAINING 9 NPDS-5 DEVICES THAT RESULTED IN AN AE. (THE LITERATURE INDICATES THAT NPDS-5 WAS PLACED IN PATIENTS WITH PF IN THE DB-ERP GROUP AND USED IN EUS-PD GROUP. AS PER TABLE 2, 8 PATIENTS WERE TREATED FOR PF IN DB-ERP GROUP AND 9 PATIENTS WERE TREATED IN EUS-PD. NPDS-5 WAS POTENTIALLY USED IN 17 PATIENTS).
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
510(K): K171623. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
KOGURE ET AL 2020 ¿ENDOSCOPIC MANAGEMENT OF PANCREATIC DISEASES IN PATIENTS WITH SURGICALLY ALTERED ANATOMY: CLINICAL OUTCOMES OF COMBINATION OF DOUBLE-BALLOON ENDOSCOPY- AND ENDOSCOPIC ULTRASOUND-GUIDED INTERVENTIONS¿ THE CURRENT STUDY AIMED TO RETROSPECTIVELY EVALUATE THE FEASIBILITY, EFFECTIVENESS, AND SAFETY OF A COMBINATION OF DBE ASSISTED AND EUS-GUIDED PANCREATIC INTERVENTIONS IN PATIENTS WITH SURGICALLY ALTERED ANATOMY. A SINGLE-CENTER RETROSPECTIVE ANALYSIS OF PATIENTS WITH SURGICALLY ALTERED ANATOMY WHO UNDERWENT PANCREATIC INTERVENTIONS VIA SHORT DOUBLE-BALLOON ENDOSCOPE-ASSISTED ERP (DB-ERP) AND ENDOSCOPIC ULTRASONOGRAPHY- GUIDED PANCREATIC DUCT DRAINAGE (EUS-PD) BETWEEN OCTOBER 2006 AND JUNE 2019. SURGICALLY ALTERED ANATOMY UNDERGOING ENDOSCOPIC TREATMENT (DB-ERP, EUS-PD, OR BOTH) FOR PANCREATIC DISEASES WERE STUDIED. DB-ERP: SELECTIVE CANNULATION TO THE PANCREATIC DUCT WAS ATTEMPTED VIA A CONTRASTASSISTED OR WIRE-GUIDED METHOD USING A STRAIGHT CANNULA(0.025-INCH ERCP CATHETER; MTW ENDOSKOPIE, WESEL,GERMANY) OR A ROTATABLE SPHINCTEROTOME (TRUETOME; BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA) WITH A 0.035- OR 0.025-INCH HYDROPHILIC GUIDEWIRE (RADIFOCUS; TERUMO, TOKYO, JAPAN). IN CASES WITH SEVERE STRICTURE OR OBSTRUCTION OF THE PJ ANASTOMOSIS, A METAL-TIP CANNULA(PR-132Q; OLYMPUS) AND A 0.018-INCH HYDROPHILIC GUIDEWIRE (RADIFOCUS) WERE USED. SUBSEQUENTLY, THE GUIDEWIRE WAS REPLACED WITH A 0.025-INCH STIFF GUIDEWIRE(REVOWAVE; PIOLAX MEDICAL DEVICES, KANAGAWA, JAPAN) TO USE WIRE-GUIDED DEVICES, SUCH AS A BALLOON DILATION CATHETER, A BASKET CATHETER, AND AN EXTRACTION BALLOON CATHETER. THE DIAMETER OF THE DILATION BALLOON WAS SELECTED NOT EXCEEDING THAT OF THE PANCREATIC DUCT PROXIMAL TO THE STRICTURE. IF THE WAIST OF THE BALLOON DID NOT DISAPPEAR AND THE STRICTURE WAS CONSIDERED PERSISTENT, A 5- OR 7-FR TRANSANASTOMOTIC PANCREATIC STENT WAS INSERTED (GEENEN; COOK MEDICAL, BLOOMINGTON, IN, USA, FIG. 2). PANCREATIC STENT WAS EXCHANGED EVERY 3 MONTHS AND THE NUMBER OF STENTS WAS INCREASED, IF POSSIBLE, UNTIL THE STRICTURE RESOLUTION WAS CONFIRMED. PDSS WERE EXTRACTED USING BASKET AND EXTRACTION BALLOON CATHETERS IN A RETROGRADE MANNER FOLLOWING BALLOON DILATION OF THE ANASTOMOTIC STRICTURE OR AMPULLA.26 IN PATIENTS WITH PF, A 5-FR NASOPANCREATIC CATHETER WAS PLACED (NPDS-5; COOK MEDICAL). EUS-PD: A 0.025-INCH GUIDEWIRE (VISIGLIDE2; OLYMPUS) WAS INTRODUCED INTO THE PANCREATIC DUCT, AND IF POSSIBLE, PASSED THE STRICTURE INTO THE JEJUNUM. AFTER DILATION OF THE PANCREATICOGASTROSTOMY TRACT USING A 4-MM BALLOON CATHETER AND/OR A CAUTERY DILATOR, A 5- OR 7-FR TRANS-MURAL PANCREATIC STENT (GEENEN, COOK MEDICAL; ZIMMON, COOK MEDICAL; FLEXIMA, BOSTON SCIENTIFIC; OR THROUGH & PASS, GADELIUS MEDICAL, TOKYO, JAPAN) OR A 5- FR NASOPANCREATIC CATHETER WAS INSERTED IN AN ANTEGRADE MANNER (FIG. 3). IN PATIENTS WITH PJAS, A PANCREATIC STENT WAS PLACED ACROSS THE STRICTURE, IF POSSIBLE. PDS WAS ANTEGRADELY PUSHED OUT USING AN EXTRACTION BALLOON CATHETER. PRIOR SURGERY AND GASTROINTESTINAL RECONSTRUCTION WERE PANCREATICODUODENECTOMY (PD) WITH BILLROTH-II IN 26 (45.0%), PD WITH ROUX-EN-Y (R-Y) IN 10 (25.0%), PD WITH IMANAGA METHOD IN ONE (2.5%), AND DISTAL GASTRECTOMY WITH R-Y IN THREE (7.5%). PANCREATICOJEJUNOSTOMY ANASTOMOTIC STRICTURE WAS TREATED BY BALLOON DILATION ALONE IN 11 PATIENTS AND BALLOON DILATION WITH STENT PLACEMENT IN 18 PATIENTS. THE RATE OF STRICTURE RESOLUTION VIA PLASTIC STENT PLACEMENT WAS 33.3% (6/18) WITH A MEDIAN STENT INDWELLING TIME OF 9.6 MONTHS (IQR, 6.6¿13.1 MONTHS). STRICTURE RECURRENCE AFTER STENT REMOVAL WAS OBSERVED IN THREE PATIENTS (50%) AFTER 3.3, 7.6, AND 13.6 MONTHS FROM STENT REMOVAL, WHICH WAS MANAGED BY PLASTIC STENT PLACEMENT AGAIN. ADVERSE EVENTS WERE OBSERVED IN 12.2% (5/41) AFTER DBERP: ONE PERFORATION (MODERATE, 1) AND FOUR PANCREATITIS (MODERATE, 3; MILD, 1). IN ONE PATIENT WITH PERFORATION, PNEUMOPERITONEUM WAS OBSERVED ON FLUOROGRAPHY DURING PANCREATIC CANNULATION USING A METAL-TIP CANNULA. A 5-FR CATHETER WAS LEFT IN THE AFFERENT LIMB TO AVOID LEAKAGE OF BILE AND PANCREATIC JUICE, AND THE PATIENT REMAINED ASYMPTOMATIC WITHOUT SUBSEQUENT PERITONITIS. TOGETHER WITH SEVEN SALVAGE PROCEDURES, THE ADVERSE EVENT RATE OF EUS-PD WAS 55.6% (5/9): THREE PANCREATIC LEAKAGE (MODERATE, 2; MILD, 1) AND TWO ABDOMINAL PAIN (MILD, 2) RPN: NPDS-5 THIS FILE IS BEING CREATED TO CAPTURE THE OFF LABEL USE OF THE 8 NPDS-5 DEVICES AS THEY WERE PLACED IN SURGICALLY ALTERED ANATOMY. USER ERROR IS ALSO RELATED TO THIS FILE AS INCORRECT WIRE GUIDE WAS USED. AN ADDITIONAL COMPLAINT WAS CREATED TO CAPTURE OFF LABEL RELATED TO THE REMAINING 9 NPDS-5 DEVICES THAT RESULTED IN AN AE. (THE LITERATURE INDICATES THAT NPDS-5 WAS PLACED IN PATIENTS WITH PF IN THE DB-ERP GROUP AND USED IN EUS-PD GROUP. AS PER TABLE 2, 8 PATIENTS WERE TREATED FOR PF IN DB-ERP GROUP AND 9 PATIENTS WERE TREATED IN EUS-PD. NPDS-5 WAS POTENTIALLY USED IN 17 PATIENTS)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1064481 | NASAL PANCREATIC DRAINAGE SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male |