MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932)

Event Date 06/15/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation- evaluation: it was reported that patients experienced biliary hemorrhage and cholangitis from a 7f or 8.5f biliary drainage catheter.This incident was received from a literature article written by zheng, et al.From the cancer hospital of china medical university, liaoning cancer hospital and instit, in china.No additional adverse effects were reported.A review of the complaint history, device history record, instructions for use (ifu), and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A search to determine the identity of the product was completed with the information from the article and available sales records.The search determined the rpn to be ult8.5-38-40-p-32s-clb-rh.The device history record (dhr) could not be reviewed due to lack of lot information from the user facility.A search for lots sold to the customer on the determined rpn could not specify the exact lot affected, however a nonconformance search and complaints search found no nonconformances relevant to the failure mode or complaints reported from the field.Based on this information, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Product labeling was also reviewed.Instructions for use are packaged with this device.Relevant sections include: how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no returned product for evaluation, and results of the investigation, it was concluded that it¿s possible the patient anatomy or procedure contributed to the failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9412924
• MDR Text Key: 169199269
• Report Number: 1820334-2019-03011
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other,user
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other