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 Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 10/23/2015

Event Type  Injury  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

During a liver, biliary drain procedure on the patient, the staff noticed the drain was leaking from the catheter, just under the maclloc hub.The device was removed there was a drain exchange.The patient had to have the drain replaced so a new one was inserted: the biliary drain needed to be exchanged, as the product with complaint had a leak.No other adverse effects to the patient were reported due to this occurrence.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7032537
• MDR Text Key: 92039975
• Report Number: 1820334-2017-04020
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)180325(10)5749178
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR