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

Catalog Number ULT14.0-38-40-P-32S-CLB-RH

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 the transplanted kidney and bladder of a patient during a nephroureteral drainage procedure at an unspecified date.Hub separation from the catheter was reported to have happened two times, one week apart.In the first occurrence, it was found post procedure that the catheter had separated from the hub.The defective catheter was removed and replaced with a like device.A section of the device did not remain inside the patient¿s body.The second occurrence is detailed in medwatch 1820334-2018-02532.

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 and specifications of the device was conducted during the investigation.The complaint device was not returned but is associated with another complaint of which the device was returned.The devices are from different lots but are associated with the same failure mode on the same patient.In the associated complaint investigation, the device was returned with the catheter detached from the hub.The catheter was cut in two pieces, but no additional damage was noted to the catheter or the mac-loc hub.The catheter flare appeared to be slightly shallow and damaged, but due to the compression of the flare within the hub and the potential for damage upon removal, it cannot be determined if the flare was manufactured to specifications.Dimensional analysis confirmed that all other components of the device had been manufactured within the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.Proper procedures are in place to identify and prevent this failure mode prior to device distribution.The instruction for use (ifu) instruct the user to inspect the device prior to use to ensure that no damage has occurred.A review of the device history record revealed nonconformances for three devices that were found to have surface defects.All affected devices were scrapped out prior to device distribution.Nonconformances were also reported for the catheter tubing subassembly for one device that was reworked for incorrect quantity and one device that was scrapped out for bad pattern.It should be noted that there are no other complaints reported for this lot number.Based on the information provided, the examination of a like product and the results of our investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.Per the quality engineering risk assessment no further action is required the appropriate personnel have been notified and cook 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.

Event Description

No new event description information to report at this time.

• 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: 7852370
• MDR Text Key: 119419085
• Report Number: 1820334-2018-02359
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002095007
• UDI-Public: (01)00827002095007(17)201004(10)8269409
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2020
• Device Catalogue Number: ULT14.0-38-40-P-32S-CLB-RH
• Device Lot Number: 8269409
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention