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

Catalog Number ULT8.5-38-25-P-5S-CLDM-WF-HC

Device Problem Aspiration Issue (2883)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  malfunction  

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 Description

It was reported during a percutaneous transhepatic cholangiography drainage (ptcd) procedure, the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter would not function due to air aspiration.The device was removed and replaced with a like device from the same lot and the same failure occurred.A third device from a different lot was then used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

D10: device available for eval? yes; product received on: 12jul2018.A2&a4:asku.Investigation/evaluation: h6: conclusion codes: cause not established (4315).A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/functional test of the returned devices were conducted during the investigation.Customer returned two 8.5fr mac-loc catheters in a used condition.Biomatter was present on both devices.There are two additional drainage holes at 6cm and 7.5cm from the distal tip, likely made by the customer, on one of the devices (catheter 1).Catheter 1 was noted to have hemostat marks on the cap.The customer also returned one unopened 8.5fr mac-loc catheter.No biomatter was present on the device.No surface damage was present on the device.The outer diameter of the catheter tubing, connector cap distal inner diameter, mac-loc hub distal inner diameter, and the number of adapter threads showing were recorded for the three devices.All measurements were within cook's manufacturing specifications except for the number of adapter threads on catheter 1; too many were showing.Cook is aware of this issue and has recently retrained the manufacturing department in a defect awareness training.The three devices were leak tested.A leak was confirmed in the two used devices but was not present in the unopened device.A tug and twist test of each device revealed that the proximal assemblies were secure.The connector caps were removed for each device.The suture string of catheter 1 was found to be partially wound in the threads.The flare appeared slightly lopsided.The suture string of catheter 2 was found wound in the threads.The flare appeared lopsided, had a lip.The suture string of the unopened device was found wound in the threads.The flare had a lip.Due to the compression of the flare within the cap, it cannot be determined whether the flares were manufactured to cook's specifications.Additionally, a document based investigation evaluation was performed.A review of the device history record showed 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 information provided, the examination of the returned product, and the results of our investigation, one actual root cause was determined to be cause traced to manufacturing (manufacturing deficiency) -catheter 1.No root cause was determined - catheter 2.We have notified the appropriate personnel of this event.Appropriate measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.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 DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7659250
• MDR Text Key: 113190779
• Report Number: 1820334-2018-01898
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002137660
• UDI-Public: (01)00827002137660(17)210221(10)8601252
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Catalogue Number: ULT8.5-38-25-P-5S-CLDM-WF-HC
• Device Lot Number: 8601252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1