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

Catalog Number	DSF1865
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gore is currently in the process of reviewing the device manufacturing papers for the lot involved in this event.Gore has requested the availability of the device for an engineering investigation.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
It was reported to gore that on (b)(6) 2026 a gore® dry seal flex introducer sheath dsf 1865 was used to perform thrombectomy in a patient with pulmonary embolism.During the procedure, blood was reportedly noted leaking through the sheath valve as if it were perforated but no leakage was observed during device preparation.Reportedly, blood loss was less than one liter and there was neither hemodynamic impairment nor was a blood transfusion administered.It was additionally reported that valve re-pressurization was attempted but would not stop the bleeding.However, the physician was reportedly able to conclude the procedure without replacing the sheath.No information was available as to the cause of the suspected sheath valve perforation.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24410977
• Report Number: 3007284313-2026-04586
• Device Sequence Number: 10577410
• Product Code: DYB
• UDI-Device Identifier: 00733132628346
• UDI-Public: (01)00733132628346(17)270319
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: DSF1865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 02/22/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 97 KG