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 Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k 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 customer reported that the ultrathane mac-loc locking loop biliary drainage catheter placed in the liver leaked at the junction between the catheter and the hub portions of the device.This issue ultimately necessitated the removal and replacement of the complaint device.The replacement reportedly occurred with no further complications or adverse events to the patient.Additional information has been requested from the customer, but no further information could be provided.The product is reportedly unavailable for return and evaluation.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation a review of documentation, drawings, manufacturing instructions, instructions for use (ifu), trends, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complainant device lot number is unknown.Thus, a review of the device history record, nonconformance history, and related product complaints query could not be conducted.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.However, measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed 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: 7210981
• MDR Text Key: 97942000
• Report Number: 1820334-2018-00075
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention