LIGUORY NASAL BILIARY DRAINAGE SET
Report
- Report Number
- 3001845648-2020-00493
- Event Type
- Injury
- Date Received
- August 12, 2020
- Date of Event
- May 22, 2019
- Report Date
- October 27, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PMA/510 (K) #: K180868. THIS REPORT BEING SUBMITTED IS A COMPLETE FOLLOW UP MDR FOLLOWING THE INVESTIGATION BEING SIGNED OFF ON 27-OCT-2020. DEVICE EVALUATION THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW 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 ALL 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. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0099-0). ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PATIENT¿S RECEIVING CANCER TREATMENT POST STENT PLACEMENT. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT THE PATIENT'S HAD PRE-EXISTING CONDITION OF HILAR CHOLANGIOCARCINOMA. IT IS POSSIBLE THAT IF THE PATIENTS RECEIVED ANY FORM OF TREATMENT FOR THEIR CANCER (E.G. CHEMOTHERAPY) IT MAY HAVE RESULTED IN THEIR TUMOURS SHRINKING AND THE DRAINAGE CATHETERS MIGRATING. SUMMARY THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE EVALUATION: THE UNKNOWN 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 RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL 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. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0099-0). IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PATIENT¿S RECEIVING CANCER TREATMENT POST STENT PLACEMENT. FROM THE AVAILABLE INFORMATION IT IS KNOWN THAT THE PATIENT'S HAD PRE-EXISTING CONDITION OF HILAR CHOLANGIOCARCINOMA. IT IS POSSIBLE THAT IF THE PATIENTS RECEIVED ANY FORM OF TREATMENT FOR THEIR CANCER (E.G. CHEMOTHERAPY) IT MAY HAVE RESULTED IN THEIR TUMOURS SHRINKING AND THE DRAINAGE CATHETERS MIGRATING. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
BA ET AL 2020 (ENBD UKN) - "PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE MAY BE THE PREFERRED PREOPERATIVE DRAINAGE METHOD IN HILAR CHOLANGIOCARCINOMA". PROCEDURE : GENERALLY SPEAKING, ENBD WAS PERFORMED WHEN PATIENTS HAD DIFFICULTY DURING CONTRAST AGENT EXCRETION, OR WHEN BILE WAS THICK OR FULL OF DREGS, WHICH IS EASY TO CLOG DRAINAGE TUBES. THE UPPER EDGE OF PLASTIC STENTS AND THE TIP OF THE NASOBILIARY CATHETER (8 FR/10.2 FR; COOK MEDICAL, WINSTON-SALEM, NORTH CAROLINA, UNITED STATES) SHOULD CROSS OVER THE UPPER MARGIN OF THE MALIGNANT OBSTRUCTION SITE BY 2 CM. FIFTY-FIVE OF 180 PATIENTS (30.56 %) DEVELOPED POST-DRAINAGE CHOLANGITIS: 37 IN THE ERCP GROUP AND 18 IN THE PTBD GROUP. AMONG THEM, 46 CASES (83.64 %) OF POST-PROCEDURE ACUTE CHOLANGITIS WERE CONSIDERED AS BACTERIAL CONTAMINATION ORIGINATING FROM THE DUODENUM, EIGHT CASES (14.55 %) WITH DRAINAGE TUBE MIGRATION ((B)(4)) AND 1 CASE (1.81 %) WITH BLOCKAGE OF DRAINAGE TUBE CAUSED BY HEMOBILIA ((B)(4)MOST FEVERS OCCURRED WITHIN 24 HOURS AFTER INTERVENTION. : DIAGNOSTIC CRITERIA FOR ACUTE CHOLANGITIS WERE BASED ON THE TG13 TOKYO GUIDELINES AND INCLUDED:(1) UPPER ABDOMINAL PAIN (NRS = 4); (2) FEVER (> 38.0)AND/OR CHILLS; (3) SERUM TOTAL BILIRUBIN (TBIL) LEVEL > 34.2 MOL/L; AND (4) INFLAMMATORY RESPONSE (WBC > 10,000/L, CRP>1MG/DL). THIS FILE WILL CAPTURE EIGHT CASES OF POST DRAINAGE CHOLANGITIS CAUSED BY DRAINAGE TUBE MIGRATION. THIS REPORT BEING SUBMITTED IS A COMPLETE FOLLOW UP MDR FOLLOWING THE INVESTIGATION BEING SIGNED OFF ON 27-OCT-2020.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
PMA/510 (K) #: K180868. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
BA ET AL 2020 (ENBD UKN) - "PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE MAY BE THE PREFERRED PREOPERATIVE DRAINAGE METHOD IN HILAR CHOLANGIOCARCINOMA". PROCEDURE : GENERALLY SPEAKING, ENBD WAS PERFORMED WHEN PATIENTS HAD DIFFICULTY DURING CONTRAST AGENT EXCRETION, OR WHEN BILE WAS THICK OR FULL OF DREGS, WHICH IS EASY TO CLOG DRAINAGE TUBES. THE UPPER EDGE OF PLASTIC STENTS AND THE TIP OF THE NASOBILIARY CATHETER (8 FR/10.2 FR; COOK MEDICAL, WINSTON-SALEM, NORTH CAROLINA, UNITED STATES) SHOULD CROSS OVER THE UPPER MARGIN OF THE MALIGNANT OBSTRUCTION SITE BY 2 CM. FIFTY-FIVE OF 180 PATIENTS (30.56 %) DEVELOPED POST-DRAINAGE CHOLANGITIS: 37 IN THE ERCP GROUP AND 18 IN THE PTBD GROUP. AMONG THEM, 46 CASES (83.64 %) OF POST-PROCEDURE ACUTE CHOLANGITIS WERE CONSIDERED AS BACTERIAL CONTAMINATION ORIGINATING FROM THE DUODENUM, EIGHT CASES (14.55 %) WITH DRAINAGE TUBE MIGRATION ((B)(4)) AND 1 CASE (1.81 %) WITH BLOCKAGE OF DRAINAGE TUBE CAUSED BY HEMOBILIA ((B)(4)). MOST FEVERS OCCURRED WITHIN 24 HOURS AFTER INTERVENTION. DIAGNOSTIC CRITERIA FOR ACUTE CHOLANGITIS WERE BASED ON THE TG13 TOKYO GUIDELINES AND INCLUDED:(1) UPPER ABDOMINAL PAIN (NRS = 4); (2) FEVER (> 38.0) AND/OR CHILLS; (3) SERUM TOTAL BILIRUBIN (TBIL) LEVEL > 34.2 MOL/L; AND (4) INFLAMMATORY RESPONSE (WBC > 10,000/L, CRP>1MG/DL). THIS FILE WILL CAPTURE EIGHT CASES OF POST DRAINAGE CHOLANGITIS CAUSED BY DRAINAGE TUBE MIGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862730 | LIGUORY NASAL BILIARY DRAINAGE SET | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |