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

Catalog Number	DSF2265
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: code d12: ifu statements the dryseal sheath device ifu was reviewed with respect to the complaint detail for the applicable region and time period, and the following statements were identified in relation to the complaint.Warnings on applicable subjects (patients) 1.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) in accordance with the observation in ct image or angiography obtained by pre-operation / operation or visual observation obtained by operation is required to ensure successful use of gore® dryseal flex introducer sheath (flex).[if vessel size is smaller than the introducer sheath outer diameter (table 1) or if vessel is not adequate for access, major bleeding, vessel damage, or embolism, may result.] warnings on usage 1.Advance and remove this device or guidewire, catheter, or other devices through this device only under fluoroscopic guidance and confirm the location.Do not continue advancement or retraction of the device if there is resistance.Determine the location and the cause of resistance before proceeding.[if we did not confirm the location under fluoroscopic guidance or continued advancement or retraction against resistance may result in vessel damage or damage to / breakage of the device.] [sheath preparation] 2.Verify the vessel is of adequate diameter and tortuosity to accommodate the device.2.Device defects and adverse events [other adverse events] blood loss, bleeding, hematoma, embolization, ischemia, permanent ischemia, infection, vascular trauma, dissection, rupture, perforation, tear.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
On (b)(6) 2024, the patient underwent endovascular treatment of a thoracic (arch) aortic aneurysm using gore® dryseal flex introducer sheath (dsf) as an accessory.The physician attempted to raise the 22fr dsf from the right side but was unable to insert it due to the narrowness of the access vessel.As an alternative, an edwards esheath introducer set (esheath) was utilized, and the procedure was completed in accordance with the original plan.An access angiography was performed at the time of esheath removal, which confirmed the rupture of the right external iliac artery.Two additional gore® viabahn® endoprosthesis with heparin bioactive surface were placed for repair, and the procedure was completed once it was confirmed that no blood had leaked outside the vessel.The physician reportedly stated the following: the sheath was inserted by force because the access vessels were generally narrow and partially stenotic in some areas.Reportedly, the outer diameter of the dsf used in this case was 8.2 mm, whereas the vessel diameter of the access vessel was 4.4~8.5 mm.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: annex c and d codes were updated to reflect results of investigation.

• 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: mami nagashima ; 1505 n. fourth street; flagstaff, AZ ; JA ; 9285263030
• MDR Report Key: 20813636
• Report Number: 3007284313-2024-03622
• Device Sequence Number: 18625617
• Product Code: DYB
• UDI-Device Identifier: 00733132628384
• UDI-Public: 00733132628384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DSF2265
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/30/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2024
• 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: Required Intervention
• Patient Sex: Unknown