MAUDE Adverse Event Report: COOK INC ULTRATHANE BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: event occurred sometime between june 2014 to january 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." "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." "drainage tubes were routinely required to undergo cholangiography and replaced every 3-6 mo; however, there were still 10 (26.3%) patients with 13 tube shedding events." no other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation - evaluation: it was reported that the hub of the catheter within a ultrathane biliary drainage catheter separated from the shaft.This incident was reported by cancer hospital of china medical university, liaoning cancer hospital and instit, in china.No adverse effects were reported.A review of the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.The complainant did not return the complaint device for investigation; therefore, no physical examinations could be performed.Additionally, a document-based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) and a complaint search could not be completed as the lot, rpn, and date of event are unknown.At this time however, there is no evidence suggesting that nonconforming product from the reported lot exists in house or in the field.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A capa was opened previously to investigate this failure mode; root causes were determined, and corrective actions were implemented including a gap gauge and retraining.As the reported lot is unknown, it is highly likely due to the date of event that the affected lot was manufactured prior to corrective action implementation.Based on the information provided, no returned product, and results of the investigation, it was concluded a manufacturing or quality control deficiency contributed to this incident.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.

Event Description

Additional information could not be obtained from the hospital.However, interpretation from the field indicated "tube shedding" is related to the tube falling off.

• Brand Name: ULTRATHANE 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: 9411369
• MDR Text Key: 190690531
• Report Number: 1820334-2019-03012
• 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: 12/04/2019

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1