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

Model Number	DSF2633
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Code f28 is used to cover vac (vacuum-assisted closure) therapy.The device was discarded at the treating facility and was therefore not available for analysis.As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional device will be identified in this report: gore® dryseal flex introducer sheath, lot #: 25828497, catalog #: dsf1233, udi #: (b)(4).According the gore® dryseal flex introducer sheath instructions for use, adverse events that may occur and/or require intervention include, but are not limited to infection.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) 2023, the patient underwent endovascular treatment of a thoracic aneurysm, zone 0/1, using gore® dryseal flex introducer sheath.On (b)(6) 2023, the patient attended the outpatient clinic for a one-month follow-up, presenting with tenderness around the right inguinal wound and exhibiting swelling and redness.Elevated inflammatory response was noted in the blood examination, and ct revealed abscess formation on the ventral side of the right femoral artery.Consequently, the patient was admitted to the hospital for surgical drainage, which resulted in the discharge of a substantial amount of pus.Intravenous infusion of cefazolin sodium antibiotics was initiated.On (b)(6) 2023, vac (vacuum-assisted closure) therapy was administered.Pus culture results showed the presence of gpc (gram-positive cocci), leading to the addition of vancomycin hydrochloride.On (b)(6) 2023, pus culture identified the gpc to be methicillin-susceptible staphylococcus aureus (mmsa), and vancomycin was subsequently discontinued while the infusion of cefazolin sodium was continued.Given that the abscess was located in the device delivery site (ventral side of the right femoral artery), the adverse event (right inguinal abscess) is deemed to be associated with the procedure.However, in view of the insufficient evidence indicating device infection, the adverse event would not be attributed to the device.
Additional Manufacturer Narrative
H6: c19, the device history record was reviewed to ensure that each manufacturing, sterilization, and inspection operation was performed and indicated the product met specifications and procedures.According the gore® dryseal flex introducer sheath instructions for use, adverse events that may occur and/or require intervention include, but are not limited to infection.H6: updated investigation finding code c21 to c19.H6: updated investigation conclusion code from d16 to d12 and d15.

• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16594105
• Report Number: 3007284313-2023-02400
• Device Sequence Number: 14783815
• Product Code: DYB
• UDI-Device Identifier: 00733132630103
• UDI-Public: 00733132630103
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 12/28/2024
• Device Model Number: DSF2633
• Device Catalogue Number: DSF2633
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female