MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; INTRODUCER, CATHETER

Catalog Number	DSF1833
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6)2025, this patient underwent an endovascular treatment on the thoracic aorta for an unknown indication using a fenestrated physician-modified endograft (non-gore device; zenith alpha) and gore® dryseal flex introducer sheath.During the procedure, a dryseal valve leakage was found following the insertion of the sheath into the patient.Saline was leaked from the valve and bleeding could not be stopped.The physician attempted to inflate the valve for multiple times; however, the same things happened again.Another sheath was used for the procedure.The patient tolerated the procedure.The reporting physician commented as follows: the sheath was used appropriately as usual.Device malfunction was suspected.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Emdr section h6, codes c19 and d14 updated to reflect results of product history review/investigation/product evaluation.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Product investigation report conclusion: the reported failure mode, valve leakage following insertion into the patient, could not be independently confirmed.During the evaluation, the sheath valve was aspirated and inflated then the sheath was then flushed per the ifu, and no leakage was observed throughout the evaluation.The root cause of the reported failure mode could not be established with the available information.Evaluation summary: the gore® dryseal flex introducer sheath was prepared per ifu steps (gore® dryseal valve aspirated and inflated, as well as gore® dryseal flex introducer sheath flushed).No issues were encountered, while following the steps in the ifu, with the gore® dryseal flex introducer sheath preparation.The root cause of the observed ¿dryseal valve leakage¿ of the gore® dryseal flex introducer sheath was not determined because no issues were encountered when preparing the gore® dryseal flex introducer sheath per applicable ifu steps.Based on the available information, there is no indication of a manufacturing deficiency.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23059634
• Report Number: 3007284313-2025-04250
• Device Sequence Number: 15905049
• Product Code: DYB
• UDI-Device Identifier: 00733132630042
• UDI-Public: (01)00733132630042(17)280324
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: DSF1833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2025
• 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 Age: 87 YR
• Patient Sex: Male