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

Catalog Number ULT10.2-38-40-P-32S-CLB-RH

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510(k) #: not exempt, preamendment.Patient code: (b)(4) [no code available]- additional procedure required to replace device.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 biliary tract of a patient with a pleural liung effusion during a drainage procedure.The following day, the lack of air pressure within the catheter lead to the discovery of air leakage from the hub of the device.The defective catheter was then removed and a like device was opened and placed into the patient successfully.No adverse event in the patient have been reported.

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 documentation of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, the customer was able to supply a photo of the complaint device, in which discoloration between the catheter tubing and connector cap where the leak occurred was noted.Additionally, a document based investigation evaluation was performed.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode, and the technical files covering the catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The instructions for use (ifu) advise the user to inspect the product prior to use to ensure that no damage has occurred.Based on the review of current documentation, there is no evidence to suggest the existence of issues or gaps that could contribute to the release of nonconforming product related to the reported failure mode.A review of the device history record could not be completed because the lot number is unknown.Based on the information provided, no returned product and the results of our investigation, a definitive root 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.

• 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: 7877700
• MDR Text Key: 120306538
• Report Number: 1820334-2018-02755
• Device Sequence Number: 1
• Product Code: GCA
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULT10.2-38-40-P-32S-CLB-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO WIRE, PUNCTURE NEEDLE; TERUMO WIRE, PUNCTURE NEEDLE
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR