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 Code Available (3191)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: exempt.(b)(4).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 an ultrathane mac-loc locking loop multipurpose drainage catheter was used for right chest abscess drainage when the hub detached less than 24 hours after placement.The device was removed and another like device was used.The user facility performed a tug test on two unopened and unused devices from the same lot to assure there was no issue.One of the tested devices passed and one failed.The reported used device will not be returned, however, both unused devices will be returned for evaluation.
Event or Problem Description
No new event description information available at this time.
Additional Manufacturer Narrative
A review of the complaint history, dimensional verification, device history record, documentation, functional tests, and visual inspection of the returned device was conducted during the investigation.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 were no other reported complaints for this lot number.The 1 used device was not returned, however, 22 unused devices were returned - 6 open and 16 un-open.Due to device failure analysis of the returned devices, we are able to confirm the following devices for hub separation: 1 used, 5 prior to use, and 2 unused.All possible measurements of the returned devices match specifications and therefore we cannot confirm any non-conformances within this complaint.A document review was conducted which has established that proper procedures are in place to identify/prevent this failure mode prior to distribution.There is no evidence to suggest that product was not manufactured to current specifications 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.No additional risk reduction activities are required at this time.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7464060
• Report Number: 1820334-2018-01015
• Device Sequence Number: 147630
• Product Code: GBO
• UDI-Device Identifier: 00827002095045
• UDI-Public: (01)00827002095045(17)210222(10)8612552
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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 Catalogue Number: ULT14.0-38-25-P-6S-CLM-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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