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

Catalog Number	DSF1245
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2026, patient underwent an endovascular procedure to treat an acute limb ischemia utilizing a gore® dryseal flex introducer sheath (dsf sheath) as an accessory.The sheath was inserted vis distal superficial femoral artery (sfa) then advanced up and over the tight aortic bifurcation.During advancement, some resistance felt but sheath advanced appropriately.The penumbra lightningbolt device was advanced when the sheath transected in two.A sfa cutdown was required to cut the wire connecting the two parts of the sheath and facilitate removal.Physician states its possibly due the lack of a tapered introducer for the thrombectomy device, combined with the 4.0mm inner diameter of the dsf and the 4.04mm od of the lightning bolt 12 in the setting of a likely compressed/folded dsf lumen (over the tight aortic bifurcation) and the stiffness of the thrombectomy device once forced into a small lumen that caused the sheath to transect in two.There was no gore field sales associate (fsa) present.
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
Added g3/g4, h1/h2, h3, h6.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Engineering evaluation summary: the device evaluation showed the following: fracture of the sheath body was confirmed.Fracture of the coil wire was confirmed.Sheath body kinks were confirmed at five (5) locations along the leading portion of the fractured item.Circumferential compression of the sheath body was confirmed at three (3) locations along the leading portion of the fractured item.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24611887
• Report Number: 3007284313-2026-04628
• Device Sequence Number: 9841885
• Product Code: DYB
• UDI-Device Identifier: 00733132628117
• UDI-Public: (01)00733132628117(17)260626
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/14/2026

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 Expiration Date: 06/26/2026
• Device Catalogue Number: DSF1245
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female