NASAL BILIARY DRAINAGE SET
Report
- Report Number
- 3001845648-2024-00517
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- March 5, 2015
- Report Date
- August 23, 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/510(K)#: K180868 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K)#: K180868 DEVICE EVALUATION 1 X ENBD-8.5 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 2017 AND WILL CAPTURE THE OFF-LABEL USE OF ENBD-8.5 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 ENBD-8.5 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. HISTORICAL DATA NOT REVIEWED AS LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0129) STATES THE FOLLOWING: ¿THE NASAL BILIARY DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY 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 USED FOR USED FOR NECROTIC COLLECTION. 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 USED FOR NECROTIC COLLECTION,THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE ¿ AS PER THE IFU NASAL BILIARY DRAINAGE SETS IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY 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. SUMMARY FAILURE IDENTIFIED: OFF LABEL USE - 1 DEVICE CONFIRMED USED. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICES WERE USED FOR TRANSMURAL DRAINAGE OF POST INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE ¿ AS PER THE IFU NASAL BILIARY DRAINAGE SETS IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY 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. 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.
(B)(6) , 2017 ¿ TRANSDUODENAL DRAINAGE OF SYMPTOMATIC WALLED-OFF PANCREATIC NECROSIS IN A PATIENT WITH ANSA PANCREATICA ANATOMIC VARIATION ENDOSCOPIC TREATMENT PATIENT ADMITTED WITH ABDOMINAL PAIN AND FEVER UP TO 38°C. CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CECT) OF THE ABDOMEN WAS PERFORMED AND REVEALED A RESERVOIR OF WALLED-OFF NECROSIS IN THE PANCREAS HEAD AND BODY OF 85 MM × 78 MM SIZE. DURING THE STAY AT THE CLINIC AN ENDOSCOPIC TRANSDUODENAL DRAINAGE WAS PERFORMED. QUALIFICATION FOR ENDOSCOPIC DRAINAGE WAS MADE ON THE BASIS OF CLINICAL SYMPTOMS RELATED TO THE PRESENCE OF FLUID COLLECTION AND CONTRAST-ENHANCED COMPUTED TOMOGRAPHY. THE PLACE OF FISTULOTOMY WAS CHOSEN UNDER ENDOSCOPIC ULTRASONOGRAPHY (EUS)-GUIDANCE WHERE THE DISTANCE BETWEEN THE COLLECTION WALL AND THE GASTROINTESTINAL TRACT WALL IN EUS DID NOT EXCEED 1 CM. ENTEROSTOMY WAS PERFORMED WITH A GIOVANNINI CYSTOSTOME (CYSTOTOME CST-10, WILSON- COOK, IRELAND). THE STOMA BETWEEN THE LUMEN OF THE GASTROINTESTINAL TRACT AND THE CAVITY OF THE NECROTIC COLLECTION WAS WIDENED USING AN 8 MM HIGH-PRESSURE BALLOON (BOSTON SCIENTIFIC, USA). THROUGH THE STOMA AN 8.5 FR NASOCYSTIC DRAIN (WILSON- COOK, IRELAND) AND ¿DOUBLE-PIGTAIL¿ 8 FR STENTS (WILSON-COOK, IRELAND) WERE INSERTED INTO THE CAVITY OF THE COLLECTION. THE NECROTIC COLLECTION WAS IRRIGATED WITH SALINE SOLUTION (200 ML) THROUGH A NASOCYSTIC DRAIN EVERY 2 H DURING THE FIRST 48 H AND EVERY 4 H IN THE SUBSEQUENT DAYS. AS PER THE INTENDED USE OF THE NASAL BILIARY DRAINAGE SET, THE DEVICE USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. THIS FILE WILL CAPTURE OFF LABEL USE OF THE DEVICE NASAL BILIARY DRAINAGE SET FOR NECROTIC COLLECTION. NO ADVERSE EFFECTS REPORTED AS OCCURRING. 65 YEAR OLD.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 23 AUG 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28924 | NASAL BILIARY DRAINAGE SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Unknown |