MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TRI LUMEN CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	TLC140
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.Investigation findings code c21: conclusions pending results of product history review.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, a patient was being treated for an aortic aneurysm using a gore® tri-lumen catheter.After inserting the catheter, one of the side parts of the catheter broke off.The physician did one pass of the wire, and then withdrew the catheter and replaced with another.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded at the facility and is not available for analysis.The device evaluation was performed based on event description reported to gore.No devices or images were returned.The report from the physician could not be confirmed.No root cause could be determined with the available information.No manufacturing deficiencies were identified.Code a26 was used to cover that the limited information was provided.Code c20 was used to cover that no devices or images were returned, and no root cause could be determined with the available information.

• Brand Name: GORE® TRI LUMEN CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20674698
• Report Number: 3007284313-2024-03581
• Device Sequence Number: 18267615
• Product Code: DQY
• UDI-Device Identifier: 00733132644421
• UDI-Public: 00733132644421
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: TLC140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female