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

Catalog Number	DSF1633
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
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 information was reported to gore: on (b)(6) 2025, this patient underwent an endovascular treatment for abdominal aortic aneurysm and iliac artery aneurysm using gore® excluder® conformable aaa endoprosthesis, gore® excluder® aaa endoprosthesis, gore® excluder® iliac branch endoprosthesis (ibe), and gore® dryseal flex introducer sheath (dsf sheath).After successful deployment of all the planned devices, a 16 fr dsf sheath was removed and a perclose device was used for closure of the puncture site, but the device did not work properly, requiring conversion to cut-down for hemostasis.The removed dsf sheath was then reinserted for approximately 8 cm.During reinsertion, it was observed that a black wire (coil) was protruding from the sheath tube at 10 cm from the sheath tip.This portion had not entered the patient¿s body, so the cut-down and hemostasis was not affected, and the procedure was concluded without patient¿s health injury.Reportedly, preparation of the devices and technique at the start of procedure were without issues.The reporting physician commented as follows: the timing of the sheath damage was unknown.Due to the narrow access, if the sheath had been damaged inside the body, it could have caused vascular injury during removal, but there was no health injury to the patient; therefore, the protruding part was believed not to have entered the body.The cause might be related to the surgical field or device handling.
Additional Manufacturer Narrative
H6: investigation findings and conclusions were updated to reflect the results of investigation.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: engineering evaluation the reported protrusion of a black wire from the sheath body during a second insertion was confirmed through evaluation of the returned device.The returned dryseal sheath exhibits a kink approximately 10cm from the leading end of the sheath body.The wire coil integrated in the sheath assembly was broken at the kink location, and the broken ends protruded from the sheath.The timing and cause for the kink and broken coil could not be established with the available information; however, there was no reported sheath kink nor damage until the protruding wire was observed as the sheath was being inserted for the second time during the procedure.Further, there was no vessel trauma indicating the wire protruded while the dryseal sheath was in the patient.This indicates the sheath was likely kinked or damaged during manipulation following its first removal from the patient as reported.

• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23861530
• Report Number: 3007284313-2025-04473
• Device Sequence Number: 15790249
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: (01)00733132630028(17)280721
• 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): 03/11/2026

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: DSF1633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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
• Patient Age: 76 YR
• Patient Sex: Female