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

Model Number	DSF2265
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2021, this patient underwent debranch endovascular treatment using gore® tag® conformable thoracic stent grafts with active control system and a gore® dryseal flex introducer sheath for an aortic arch aneurysm.The planned access route was the right femoral artery, but the physician mistakenly inserted the sheath from the right superficial femoral artery.However, the procedure was continued without being noticed about the mistake.After all procedures were completed and the sheath was removed, dissection at the site of sheath insertion was revealed by abnormal blood pressure, and the site of the sheath insertion was found to be the right superficial femoral artery, not the right femoral artery.Replacement of the dissected part was performed for repair.The physician reportedly stated as below: a young, inexperienced physician performed the insertion part of the procedure, and made a mistake in the insertion site.

• 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
• MDR Report Key: 12180921
• Report Number: 3007284313-2021-01506
• Device Sequence Number: 1622162
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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 Expiration Date: 02/12/2024
• Device Model Number: DSF2265
• Device Catalogue Number: DSF2265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR