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

Catalog Number	ULT12.0-38-40-P-32S-CLB-RH
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/25/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
During a biliary drainage catheter placement, the physician placed a 12fr billiary drainage catheter and the device leaked at the hub.The physician then placed a 14fr biliary drainage catheter with no complications.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Common Device Name: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7028554
• Report Number: 1820334-2017-04024
• Device Sequence Number: 11058838
• Product Code: GCA
• UDI-Device Identifier: 00827002094994
• UDI-Public: (01)00827002094994(17)180421(10)5822960
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: ULT12.0-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention