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

Catalog Number ULT8.5-38-40-P-32S-CLB-RH

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Date of event early in the year 2018.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that an ultrathane mac-loc locking loop biliary drainage catheter was placed into the right upper quadrant of the patient during a biliary drainage procedure.The flexible stiffening cannula became difficult to remove from the catheter during the procedure.The stiffener was able to be removed over the wire but was elongated in the process.A replacement catheter was not needed and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Investigation - evaluation.A review of the documentation, drawing, instructions for use (ifu), manufacturing instructions and quality control of the device was 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.There is no evidence to suggest issues or gaps exist which could contribute to the release of nonconforming product related to the reported failure mode.A precaution noted in the instructions for use (ifu) states that when inserting the stiffening cannula into a catheter with a retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.A review of the device history record could not be performed, as the lot number is unknown.Based on the information provided, no returned product and the results of our investigation, a definitive cause can be traced to the user.It is likely that the customer did not use the stiffener and catheter together appropriately, causing the flexible stiffener to become lodged.This could be a result of not following the instructions for use by not holding the suture taut when inserting the flexible stiffener into the catheter.This could also be from allowing biomatter to clog within the catheter although this could not be confirmed.The appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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: 7804692
• MDR Text Key: 117856051
• Report Number: 1820334-2018-02469
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1