MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Catalog Number	ULT14.0-38-25-P-6S-CLM-RH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the user facility experienced hubs detaching from ultrathane mac-loc locking loop multipurpose drainage catheters.This medwatch report addresses sixteen unused devices the facility returned for evaluation.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation and visual inspection/dimensional verification/functional test, of the returned devices was conducted during the investigation.Device failure analysis identified 12 devices to show contributing factors of hub separation; one of the opened devices and 11 of the unopened devices.The opened device was returned already in a separated state.One of the flares within the unopened devices was easily pulled out by tug method.10 more unopened devices were found to have a loose cap and a large amount of suture stuck within the threads of the mac-loc and cap.Therefore this complaint will confirm 12 devices; 1 prior to use and 11 unused.All possible measurements were within specifications and therefore we cannot confirm these devices to be non-conforming.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there is one other reported complaint for this lot number.Document review has established that proper procedures are in place in order to identify/prevent this failure mode prior to distribution.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
No new event description information to report at this time.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7489822
• Report Number: 1820334-2018-01247
• Device Sequence Number: 1314537
• Product Code: GBO
• UDI-Device Identifier: 00827002095045
• UDI-Public: (01)00827002095045(17)210102(10)8481991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ULT14.0-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1