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

Model Number	DSF1433
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis, and a gore® dryseal flex introducer sheath (dsf sheath) as an accessory in the procedure.A pull-through guidewire was created with left femoral artery to left radial artery, and the dsf sheath was inserted through the left femoral artery.Reportedly, the tortuosity at the left external artery and the origin of the left common iliac artery made it difficult to advance the dsf sheath.After insertion of the dsf sheath, it was observed that the dsf sheath was kinked due to the tortuosity of the left iliac external artery when the contralateral leg device was inserted.After the contralateral leg device was delivered to the target site, the physician attempted to remove the dsf sheath, and the physician heard a strange noise, but could not figure out the cause, so the physician continued to remove the dsf sheath.And then it was confirmed that the dsf sheath was torn, and only the proximal part of the sheath was pulled out.The torn part did not pulled down and the stent graft was still inside the torn part.So the torn part removed from the patient along with the contralateral leg device.The procedure was continued using another sheath and another contralateral leg device.The patient tolerated the procedure.It was reported that it probably the sheath was broken due to highly-calcified tortuous site, and it was torn when it was removed.
Additional Manufacturer Narrative
(b)(4).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
H6: investigation conclusion updated.
Additional Manufacturer Narrative
H1/h2 updated to malfunction.H6 codes updated to reflect investigation/evaluation findings.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15171510
• Report Number: 3007284313-2022-02070
• Device Sequence Number: 20114086
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• 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,Followup
• Report Date (Section B): 02/03/2023

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 Expiration Date: 08/13/2023
• Device Model Number: DSF1433
• Device Catalogue Number: DSF1433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 01/27/2023; 07/15/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 01/27/2023; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2021
• 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: Male