NASAL BILIARY DRAINAGE SET
Report
- Report Number
- 3001845648-2023-00689
- Event Type
- Malfunction
- Date Received
- September 8, 2023
- Date of Event
- November 4, 2021
- Report Date
- November 10, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
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 3 X ENBD-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 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-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¿. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. THE JAPANESE PACKAGING INSERT (C-ES0906F05) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. 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 USER INSERTED THE ENBD-5 DEVICES INTO THE GALLBLADDER. AS PER THE IFU, THIS DEVICE IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. WHEN THE DEVICE IS USED OUTSIDE IT'S INTENDED USE, THE EFFECTS CANNOT BE PREDICTED. THEREFORE, THE USER IS RECOMMENDED TO ADHERE TO THE IFU AND INTENDED USE. IT SHOULD ALSO BE NOTED THAT THE USER UTILISED A 0.025 INCH WIRE GUIDE WITH THE DEVICE WHICH IS CONSIDERED USER ERROR AND LINKED TO THE OFF LABEL USE. AS PER THE LABEL, A 0.035 INCH WIRE GUIDE IS RECOMMENDED FOR USE WITH THE DEVICE. SUMMARY FAILURE IDENTIFIED: OFF LABEL USE - 03 DEVICES CONFIRMED USED. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE USER INSERTED THE ENBD-5 DEVICES INTO THE GALLBLADDER. AS PER THE IFU, THIS DEVICE IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. WHEN THE DEVICE IS USED OUTSIDE IT'S INTENDED USE, THE EFFECTS CANNOT BE PREDICTED. THEREFORE, THE USER IS RECOMMENDED TO ADHERE TO THE IFU AND INTENDED USE. IT SHOULD ALSO BE NOTED THAT THE USER UTILISED A 0.025 INCH WIRE GUIDE WITH THE DEVICE WHICH IS CONSIDERED USER ERROR AND LINKED TO THE OFF LABEL USE. AS PER THE LABEL, A 0.035 INCH WIRE GUIDE IS RECOMMENDED FOR USE WITH THE DEVICE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS SUFFERED 1 CASE OF PANCREATITIS AND 2 CASES OF JAUNDICE. BOTH WERE MANAGED CONSERVATIVELY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
PMA 510K #K180868. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL FOLLOW UP REPORT BEING SUBMITTED DUE TO UPDATES MADE TO REPORTING TYPE, UPDATED FROM PRODUCT PRODUCT AND ADVERSE EVENT REPORT TO PRODUCT PROBLEM REPORT IN SECTION B.1 OF THIS REPORT ON 11-SEPT-2023.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 10-NOV-2023.
KAWAHARA, 2022 ¿ ACCURACY OF ENDOSCOPIC TRANSPAPILLARY GALLBLADDER DRAINAGE WITH LIQUID-BASED CYTOLOGY FOR GALLBLADDER DISEASE. THIS SINGLE-ARM PROSPECTIVE CLINICAL TRIAL INCLUDED A TOTAL OF 35 PATIENTS SCHEDULED TO UNDERGO ETGD BETWEEN MARCH 2017 AND SEPTEMBER 2019. A 5F PIGTAIL NASOBILIARY DRAINAGE TUBE WAS INSERTED INTO THE GALLBLADDER, AND BILE WAS COLLECTED OVER 5 TIMES; IF ETGD FAILED, A DRAINAGE TUBE WAS PLACED INTO THE BILE DUCT. THE ENDPOINTS WERE, FIRST, THE CYTOLOGICAL DIAGNOSTIC ACCURACY OF ETGD AND, SECOND, TECHNICAL SUCCESS RATES AND ADVERSE EVENTS. CONSERVATIVE TREATMENT (S3). KAWAHARA 2022: ACCURACY OF ENDOSCOPIC TRANSPAPILLARY GALLBLADDER DRAINAGE WITH LIQUID-BASED CYTOLOGY FOR GALLBLADDER DISEASE. THIS SINGLE-ARM PROSPECTIVE CLINICAL TRIAL INCLUDED A TOTAL OF 35 PATIENTS SCHEDULED TO UNDERGO ETGD BETWEEN MARCH 2017 AND SEPTEMBER 2019. A 5F PIGTAIL NASOBILIARY DRAINAGE TUBE WAS INSERTED INTO THE GALLBLADDER, AND BILE WAS COLLECTED OVER 5 TIMES; IF ETGD FAILED, A DRAINAGE TUBE WAS PLACED INTO THE BILE DUCT. THE ENDPOINTS WERE, FIRST, THE CYTOLOGICAL DIAGNOSTIC ACCURACY OF ETGD AND, SECOND, TECHNICAL SUCCESS RATES AND ADVERSE EVENTS. THIS COMPLAINTS CAPTURES OFF LABEL USE FOR THE ENBD DEVICE USED IN THE GALLBLADDER, USER ERROR FOR USE OF 0.025¿ WITH THE DEVICE. 1 CASES OF PANCREATITIS AND 2 CASE OF JAUNDICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510183 | NASAL BILIARY DRAINAGE SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |