LIGUORY NASAL BILIARY DRAINAGE SET
Report
- Report Number
- 3001845648-2020-00279
- Event Type
- Injury
- Date Received
- May 6, 2020
- Date of Event
- January 1, 2013
- Report Date
- October 20, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
PMA/510(K) #: K180868. THE UNKNOWN ENBD DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ENBD DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿COMPLICATIONS ASSOCIATED WITH NASAL BILIARY DRAINAGE INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE COMMON BILE DUCT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, BLOCKAGE OF THE DRAINAGE CATHETER, NASAL IRRITATION AND/OR SORE THROAT.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE IFU. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. INPUT RECEIVED FROM THE MEDICAL ADVISOR SUGGESTED SEVERAL POTENTIAL ROOT CAUSES BUT AS THERE IS INSUFFICIENT INFORMATION AVAILABLE WITHIN THE LITERATURE ARTICLE PERTAINING TO THE CAUSE OF THE ADVERSE EVENT, IT IS NOT POSSIBLE TO DETERMINE WHICH ROOT CAUSE WAS THE MOST LIKELY. POTENTIAL ROOT CAUSES INCLUDE KINKING OF THE CATHETER, SLUDGE/BIOFILM INSIDE THE CATHETER DUE TO PATIENT PRE-EXISTING CONDITIONS OR THE PHYSICIAN NOT PERIODICALLY EVALUATING THE CATHETER FOR PATENCY (THERE IS NO EVIDENCE TO SUGGEST THE PHYSICIAN DID NOT MONITOR STENT PATENCY THIS IS MERELY LISTED A GENERAL POTENTIAL ROOT CAUSE FOR OBSTRUCTION). THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THERE WAS 09 CASES OF ENBD OBSTRUCTION WHICH REQUIRED ENBD EXCHANGE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO THE INVESTIGATION BEING COMPLETED ON 20-OCT-2020. KAWASHIMA ET AL 2013 - PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE IN 164 CONSECUTIVE PATIENTS WITH SUSPECTED PERIHILAR CHOLANGIOCARCINOMA TO ASSESS THE CLINICAL BENEFITS OF PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) IN PATIENTS WITH PERIHILAR CHOLANGIOCARCINOMA. THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ENBD (RPN UNKNOWN), ENBD-5 LIGUORY, ENBD-5 LIGUORY-RT, ENBD-7, ENBD-7 LIGUORY-C, ENBD-7-LIGUORY-RT, ENBD-7-NAG-C. 9 CASES OF ENBD OBSTRUCTION REQUIRING ENBD EXCHANGE.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. AS THE RPN IS UNKNOWN THE PMA/510(K)# FOR THE ENDB FAMILY IS K180868.
KAWASHIMA ET AL 2013 - PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE IN 164 CONSECUTIVE PATIENTS WITH SUSPECTED PERIHILAR CHOLANGIOCARCINOMA TO ASSESS THE CLINICAL BENEFITS OF PREOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) IN PATIENTS WITH PERIHILAR CHOLANGIOCARCINOMA. THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ENBD (RPN UNKNOWN), ENBD-5 LIGUORY, ENBD-5 LIGUORY-RT, ENBD-7, ENBD-7 LIGUORY-C, ENBD-7-LIGUORY-RT, ENBD-7-NAG-C. 9 CASES OF ENBD OBSTRUCTION REQUIRING ENBD EXCHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491365 | LIGUORY NASAL BILIARY DRAINAGE SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |