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 Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: not exempt; pma/510(k) #: pre-amendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that an ultrathane mac-loc locking loop biliary drainage catheter was placed into a patient during an unknown procedure.Directly after insertion of the device, the physician discovered air leakage around the locking string of the hub.It is unknown how the procedure was completed.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation - evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a functional test, visual inspection and dimensional verification of the returned device was conducted during the investigation.One unlocked 8.5fr mac-loc catheter was returned for evaluation in used condition.Biological matter was present within the lumen of the device with no additional surface damage noted.Upon locking the device, an audible clicking sound was heard.This likely indicates that the silicone insert was not properly positioned in the hub.Upon removal of the hub, the silicone insert was not present within the hub.A leak test was conducted and confirmed the presence of a leak at the suture hole on the hub.Tug and twist tests revealed that the proximal assembly was secure.Upon removal of the connector cap, the suture string was found normal in the threads.The flare appeared lopsided, had a lip and was missing a portion, but due to the compression of the flare within the cap and the potential for damage upon removal, it cannot be determined if the flare was manufactured to specifications.Additionally, a document based investigation evaluation was performed.A review of the device history record revealed no nonconforming events which could contribute to this failure mode.It should be noted that there were no other complaints reported in this lot number.Based on the information provided, the examination of the returned product and the results of our investigation, a definitive cause can be traced to manufacturing.Device leakage was due to the lack of the silicone disc in the hub.Appropriate measures have been taken to address this failure mode.Cook will continue to monitor for similar events.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 BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7818906
• MDR Text Key: 118402260
• Report Number: 1820334-2018-02124
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)210416(10)8776069
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2021
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 8776069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1