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

Catalog Number	DSF1233
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient underwent an endovascular procedure to treat a left limb symptomatic venous obstruction using two gore® viafort vascular stents.A gore® dryseal sheath was used to access the left common femoral vein during the procedure.According to the report, access site complications were noted whereby the physician had difficulty withdrawing the device delivery catheter out of the sheath.The nature of the access site complications and the cause of the difficulty in withdrawing the delivery system through the sheath are unknown.The physician reportedly pulled the delivery system partially into the sheath.An attempt was made to remove the sheath and delivery system together, but both reportedly got stuck at the level of the venotomy.It was reported the physician made a surgical cutdown to remove the sheath and stent delivery system together to minimize vessel damage.Blood loss was estimated at 30ml, and no blood transfusion was required.The procedure was concluded without any further reported adverse events, and the patient tolerated the procedure.Multiple attempts were made by gore to obtain additional event information; however, no further information was provided.
Additional Manufacturer Narrative
H6: code e2402 used to capture unspecified access site complications.H6 - code c19: the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and indicated the product met creganna medical specifications and procedures.H6 ¿ code d15: the primary reported complaint could not be independently confirmed because there were no items returned for evaluation.The cause for the complaint could not be established with the available information.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.

• 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19906686
• Report Number: 3007284313-2024-03405
• Device Sequence Number: 20626515
• Product Code: DYB
• UDI-Device Identifier: 00733132629961
• UDI-Public: 00733132629961
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/05/2024

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: 04/25/2025
• Device Catalogue Number: DSF1233
• 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: 07/08/2024
• Initial Report FDA Received Date: 08/05/2024
• Date Device Manufactured: 05/26/2023
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White