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

Catalog Number	GDSF1633
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, the patient underwent an endovascular procedure to treat an aneurysm, utilizing gore® dryseal flex introducer sheath.It was reported, during the procedure.There was difficulty removing the sheath after successfully implanting gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprosthesis.The front portion of the sheath broke, about 3-5cm from the tip of the sheath.It was also reported the sheath was removed with a cutdown, after it snapped while attempting to remove it.The patient tolerated the procedure.It was reported the physician believes the interaction with the pro glide (closure device) likely caused the difficulty in removing the sheath.Code 5309-c: -endovascular inter 1ry procedure: other/unknown-used to capture cutdown that was made in order to remove the sheath.
Additional Manufacturer Narrative
H6: code b01 - results pending completion of device analysis.H6: code c21 - results pending completion 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.
Additional Manufacturer Narrative
Updated section g3/g4, h3, h6, and h11.H6: code c19as the device was not accessible; the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.The device was returned, and a product evaluation was performed.The following was reported: the results of the evaluation of the returned introducer sheath are consistent with the reported failure mode of removal difficulty resulting in breakage.The introducer sheath was returned in two separate segments that were attached by the device¿s metal coil.In addition, deformation was observed near the break site and extending through to the leading end.According to the reported information, the physician believes there was an interaction with the pro glide (closure device) that likely caused the difficulty removing the sheath.Therefore, the cause of the reported failure modes is attributed to the procedural interaction with other medical devices.

• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23759152
• Report Number: 3007284313-2025-04444
• Device Sequence Number: 15975271
• Product Code: DYB
• UDI-Device Identifier: 00733132658954
• UDI-Public: (01)00733132658954(17)280209
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GDSF1633
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown