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

Catalog Number	GDSF1265
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	10/16/2025
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 was reported: on (b)(6) 2025, the patient was being treated in the aortic bifurcation for bilateral common iliac artery stenosis and hypogastric artery stenosis, a gore®dryseal flex introducer sheath was being used.It was reported that during a two-hour long procedure, approximately ten minutes before finishing the procedure, the physician noticed the gore®dryseal flex introducer sheath ¿appeared to have been cut, very clean cut¿.There was no harm to the patient and the patient tolerated the procedure.Reportedly the sheath shaft was cut in the middle.It occurred inside the patient.A penumbra suction catheter system (to remove thrombus in artery) and two boston scientific angioplasty balloons were used and went through this sheath.The vbx devices were already implanted, and the sheath went through these devices.The root cause of the sheath cut is unknown.The field sales associate theorized that it potentially occurred when advancing the sheath over the bifurcation and it could have caught up on the implanted gore® viabahn® vbx balloon expandable endoprosthesis (vbx) device.
Additional Manufacturer Narrative
Gore engineering evaluation, the device evaluation showed the following: kinking in the sheath body was exhibited in multiple locations along the effective length of the introducer sheath.Sheath body tubing exhibited a single fracture location within the effective length of the introducer sheath.The root cause of the observed sheath tube kinking of the gore® dryseal flex introducer sheath could not be determined with the available information.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23528402
• Report Number: 3007284313-2025-04360
• Device Sequence Number: 21374273
• Product Code: DYB
• UDI-Device Identifier: 00733132658916
• UDI-Public: (01)00733132658916(17)270625
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K120428
• 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): 01/28/2026

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: GDSF1265
• Device Lot Number: 30716707
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male