MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature,other,user report with the FDA on 2019-12-04 for ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER N/A ULT8.5-38-40-P-32S-CLB-RH manufactured by Cook Inc.
[169199269]
Date of event: event occurred sometime between (b)(6) 2014 to (b)(6) 2017. Suspected medical device: ultrathane biliary drainage catheter, 7fr or 8. 5fr. Concomitant medical products: 22g micropuncture needle kit (cook, npas-100-rh-nt). Occupation: unknown. Pma/510(k) #: preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[169199270]
The below description of a serious injury using an ultrathane biliary drainage catheter was taken from the following article: wen-heng et al. ,? Clinical efficacy of gemcitabine and cisplatin-based transcatheterarterial chemoembolization combined with radiotherapy in hilar cholangiocarcinoma.? World journal of gastrointestinal oncology 11. 6 (2019): 489-498. The article mentions the cook "drainage tubes with a diameter of 7f or 8. 5f" were used for percutaneous biliary puncture drainage procedures. Although the exact product information cannot determined, the product is likely an ultrathane biliary drainage catheter. The following is stated in the article: "the patients were divided into either a control group or a combined treatment group according to their follow-up treatment. The control group consisted of a total of 35 patients who received simple biliary drainage tube placement and biliary stent implantation (7 patients with bilateral stents and 6 with a unilateral stent) and 22 patients receiving biliary drainage tube placement alone. The combined treatment group received tace and extracorporeal radiotherapy after biliary drainage or biliary stent implantation and consisted of a total of 37 patients, including 21 patients receiving combined treatment after biliary stent placement (14 patients with bilateral stents and 7 with a unilateral stent) and 16 undergoing combined therapy after implanting the biliary drainage tube. " "patients needed to have tubes changed every 3-6 mo. In patients where the tube could not be recanalized or detached, a drainage tube was percutaneously implanted. " "the follow-up period began after stent or drainage tube implantation until the patient quitted study or died. Laboratory tests (routine blood and urine tests, indexes of hepatic and renal function, and tumor markers) and abdominal ultrasound were reviewed once a month; liver contrast-enhanced ct or mri scans were reviewed every 3 mo. According to the imaging results and blood bilirubin levels, it was determined whether there was clogging in the biliary stent. For cases of obstructive jaundice, infection and other complications caused by biliary stent occlusion, biliary puncture drainage, anti-infection, and supportive treatments were given. " "the total bilirubin values of the control group and the combined treatment group were both less than 80 mol/l 5-6 wk after receiving biliary drainage or stent implantation. Postoperative complications included biliary hemorrhage and cholangitis. No operation-related deaths were observed within 30 d of the operation. " no other adverse effects were reported for these incidences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-03011 |
| MDR Report Key | 9412924 |
| Report Source | FOREIGN,LITERATURE,OTHER,USER |
| Date Received | 2019-12-04 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-06-15 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2019-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER |
| Generic Name | GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY |
| Product Code | GCA |
| Date Received | 2019-12-04 |
| Model Number | N/A |
| Catalog Number | ULT8.5-38-40-P-32S-CLB-RH |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-04 |