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 Problems Physical Resistance (2578); Wrinkled (2614)

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

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

G510 status: preamendment.(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

The international customer reported the ultrathane mac-loc locking loop biliary drainage catheter and stylet did not separate during percutaneous transhepatic biliary drainage.The catheter was removed from the body.The catheter was wrinkled without being removed when the stylet was pulled.There were no adverse events were reported.The patient did not require any additional procedures.The product has been received for evaluation; however, as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and trends of the device was conducted during the investigation.The device was returned and the customer's complaint is confirmed and trended as "stiffening cannula, lodges in catheter".There was waviness to the distal end of the catheter and difficulty when attempting to remove the stiffener.It was also observed that 4 mm of the cannula exited the catheter tip.The stiffener was eventually removed and the waviness within the catheter disappeared.There was no visible evidence of defects or damage to the catheter.No additional damage or defects were found within the catheter.The catheter outer diameter, end hole diameter, and inner diameter were measured to be in specifications.The outer diameter of the stiffening cannula was also found to be in specification.Review of manufacturing and quality control instructions were reviewed.Inspections are in place to recognize if the device has any defects or damage before it is shipped to the customer.Review of the ifu showed that it is unlikely that this failure mode was caused by a procedural error from the complainant.Validation procedures are in place to verify no foreign material is present inside the catheters that could contribute to increased friction between components.The device history record was not reviewed due to lot number not being provided.Additionally, a search of our complaint records based on lot was not possible.The root cause has not been confirmed at this time.This failure mode has been escalated per internal processes.The appropriate personnel have been notified and we will continue to monitor for similar complaints.

• 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: 7226059
• MDR Text Key: 98973232
• Report Number: 1820334-2018-00239
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• 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: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1