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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that the patient had to return for additional medical intervention when the hub of the ultrathane mac-loc locking loop biliary drainage catheter broke following surgery.The device was reportedly implanted on (b)(6) 2017 and replaced on (b)(6) 2017.Additional information was requested from but not provided by the customer.The product was returned for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use, manufacturing instructions, trends, and quality control data, and visual inspection, dimensional verification, and functional testing of the returned device were conducted during the investigation.Visual inspection, dimensional verification, and functional testing of the returned device noted the following: one catheter was returned with the tubing completely separated from the proximal assembly.The flare appeared to be concentric with no obvious damage from being pulled from the proximal assembly.No cracks or defects were observed on the proximal assembly.The outer diameter of the flare was measured to be 0.308", which is within the specification tolerance of the flaring iron and tubing wall thickness.The cap id was 0.190", which was also within specification.The cap was unable to be untwisted from the mac-loc subassembly.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Per the instructions for use: "upon removal from package, inspect the product to ensure no damage has occurred." review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.However, appropriate measures have been initiated to address this failure mode.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 7069242
• Report Number: 1820334-2017-04202
• Device Sequence Number: 13491846
• Product Code: GCA
• UDI-Device Identifier: 00827002095007
• UDI-Public: (01)00827002095007(17)200728(10)8102081
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/22/2018
• 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