MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® DrySeal Flex Introducer Sheath; Introducer, Catheter

Catalog Number	DSF2033
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(928)526-3030
• MDR Report Key: 50950508
• Report Number: 3007284313-2026-05117
• Device Sequence Number: 21220430
• Product Code: DYB
• UDI-Device Identifier: 00733132630066
• UDI-Public: (01)00733132630066(17)281012
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 09/30/2026

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: DSF2033
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: Required Intervention
• Patient Sex: Unknown