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

Catalog Number	DSF2465
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2025, the patient underwent endovascular treatment of a thoracic aortic aneurysm, zone 2, using gore® tag® thoracic branch endoprostheses.A 24 fr gore® dryseal flex introducer sheath was inserted via the right femoral artery.After insertion of the aortic component into the sheath, a transverse (short-axis) tear was observed on the sheath after some time.Blood leakage was noted from the tear site; therefore, the physician sealed the tear site using sterile ope tape, which successfully controlled the leakage.The same sheath was used to continue the procedure, and the procedure was completed without complication.No blood transfusion was required.Although strong resistance was reportedly encountered during device insertion, there was no noticeable catching or snagging at the tear site of the sheath.The tear site of the sheath was located on the distal portion outside the patient¿s body.It was reported that the tear site was located at the point of the maximum bend formed when holding the sheath and/or guidewire.
Additional Manufacturer Narrative
Emdr section h6, codes c19 and d15 updated to reflect results of product history review and product evaluation.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device evaluation showed the following: the sheath body exhibited circumferential deformation and kinking along its length and at its leading tip.The sheath body exhibited a breach in the laminate, resulting in leakage through the wall of the sheath body.The root cause of the observed sheath body circumferential deformation and kinking of the gore® dryseal flex introducer sheath could not be determined with the available information.The root cause of the observed breach in the sheath body laminate could not be determined with the available information.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: rie kaba ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23287243
• Report Number: 3007284313-2025-04302
• Device Sequence Number: 20223676
• Product Code: DYB
• UDI-Device Identifier: 00733132628407
• UDI-Public: (01)00733132628407(17)270807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• 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): 11/07/2025

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: DSF2465
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male