NASAL PANCREATIC DRAINAGE SET
Report
- Report Number
- 3001845648-2024-00463
- Event Type
- Malfunction
- Date Received
- August 13, 2024
- Date of Event
- April 1, 2018
- Report Date
- September 18, 2024
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PMA/ 510K#: K171623. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/ 510K#: K171623. DEVICE EVALUATION: 101X NPDS-7 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT WAS RAISED FROM LITERATURE PAPER JAGIELSKI ET AL 2018 AND WILL CAPTURE THE OFF-LABEL USE OF NPDS DEVICE. THIS FILE IS RELATED TO (B)(4). LAB EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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-7 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. HISTORICAL DATA NOT REVIEWED AS LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0107) STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER¿. THE USER IS INSTRUCTED, DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU AS THE DEVICES WERE DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT WHICH IS OFF LABEL USE. AS PER THE IFU, THIS DEVICE IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICES WERE DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT WHICH IS OFF LABEL USE. THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE AS PER THE IFU NASAL PANCREATIC DRAINAGE SETS ARE INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. AS PER THE IFU, THE USER IS INSTRUCTED NOT TO USE THE DEVICE FOR ANYTHING OTHER THAN THE INTENDED USE. CLINICAL INPUT CONFIRMED THE OFF-LABEL USE OF THE DEVICE. SUMMARY: FAILURE IDENTIFIED: OFF LABEL USE - 101 DEVICES CONFIRMED USED. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICES WERE DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT WHICH IS OFF LABEL USE. THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE AS PER THE IFU NASAL PANCREATIC DRAINAGE SETS ARE INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. AS PER THE IFU, THE USER IS INSTRUCTED NOT TO USE THE DEVICE FOR ANYTHING OTHER THAN THE INTENDED USE. CLINICAL INPUT CONFIRMED THE OFF-LABEL USE OF THE DEVICE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS DID NOT EXPERIENCE ANY HEALTH CONSEQUENCES OR ADVERSE EFFECTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.
JAGIELSKI ET AL 2018 ¿ THE DEVELOPMENT OF ENDOSCOPIC TECHNIQUES FOR TREATMENT OF WALLED-OFF PANCREATIC NECROSIS: A SINGLE-CENTER EXPERIENCE. THE STUDY GROUP COMPRISED 101 PATIENTS WITH SYMPTOMATIC WALLED-OFF PANCREATIC NECROSIS WHO UNDERWENT ENDOSCOPIC THERAPY IN OUR DEPARTMENT OVER A 5-YEAR PERIOD FROM 2011 TO 2015. IN ALL PATIENTS, AN ATTEMPT TO PERFORM TRANSMURAL DRAINAGE WAS MADE. THE PLACE OF THE TRANSMURAL TRACT WAS CHOSEN WITH EUS GUIDANCE. GASTROSTOMY(OR DUODENOSTOMY) WAS CREATED WITH THE USE OF GIOVANNINI CYSTOSTOME (CYSTOTOME CST-10, WILSON-COOK). THE FISTULA FORMED BETWEEN THE GASTROINTESTINAL LUMEN AND NECROTIC CAVITY WAS SEQUENTIALLY DILATED WITH AN 8 MM OR 20 MM BALLOON DILATOR (BOSTON SCIENTIFIC). A 7FR OR 8FR NASOCYSTIC DRAIN (BALTON OR WILSON-COOK) AND DOUBLE-PIGTAIL STENTS 7FR OR 8.5FR (ZSO-10-5, WILSON-COOK OR MAR FLOW) WERE DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT. WHEN THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED, SPHINCTEROTOMY WAS PERFORMED WITH AN OLYMPUS FLOWCUT KD-301Q0725 SPHINCTEROTOME AND PANCREATIC STENT WAS PLACED (PASSIVE TRANSPAPILLARY DRAINAGE) TO BRIDGE THE LEAK¿5FR, 7FR, 8.5FR, OR 10FR (GEENEN, ZIMMON PANCREATIC STENT, WILSON-COOK MEDICAL INC. OR MAR FLOW) (FIGURES 1(A)¿1(C)). THE STENT WAS THEN REPLACED WITH A NEW ONE AFTER 6, 12, AND 24 MONTHS OR UNTIL THE PANCREATIC DUCT LEAK WAS NO LONGER DEMONSTRATED. A 7FR OR 8FR NASOCYSTIC DRAIN (BALTON OR WILSON-COOK) AND DOUBLE-PIGTAIL STENTS 7FR OR 8.5FR (ZSO-10-5, WILSON-COOK OR MAR FLOW) WERE DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT. THIS COMPLAINT WAS OPENED TO CAPTURE THE OFF LABEL USE OF THE NPDS-7 ¿ DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT. NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY. THE STUDY GROUP COMPRISED 101 PATIENTS WITH SYMPTOMATIC WALLED-OFF PANCREATIC NECROSIS WHO UNDERWENT ENDOSCOPIC THERAPY IN OUR DEPARTMENT OVER A 5-YEAR PERIOD FROM 2011 TO 2015.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 18 SEP 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1093777 | NASAL PANCREATIC DRAINAGE SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |