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

Catalog Number DSF2233

Device Problems Material Separation (1562); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/13/2023

Event Type  Injury  

Event Description

On (b)(6), 2023, the patient underwent endovascular procedure to treat a thoracis aneurysm where the gore® dryseal flex introducer sheath (dsf2233/ (b)(6)) was used for access.Reportedly, during the procedure, the gore® dryseal flex introducer sheath was coated with diprivan to increase lubrication and minimize resistance on previous endovascular aneurysm repair access.The physician successfully placed the sheath.After successful deployment of the endoprostheses, the sheath was removed from the patient.It was reported that the radiopaque marker and the part of the introducer sheath were left in the patient in the iliac and femoral arteries.The sheath was damaged.The surgical cut-down of the access site was performed and all materials left over in the patient were removed successfully.

Manufacturer Narrative

H.6.Code c21: a review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information will be provided.The sheath will be provided for analysis.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.

Manufacturer Narrative

H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.D8/9- device was returned for analysis.B01: engineering evaluation: the sheath was sent to gore for analysis and the device evaluation confirmed the marker band and approximately 1cm of the leading end sheath material separated from the sheath.The root cause of the sheath leading end and marker ring separation could not be determined with the available information.This type of occurrence will continue to be monitored.Code c22- was used to explain that the investigation was completed, however, the cause could not be determined.Code e2402- was used to explain that the leading end of the sheath separated in the patient, however was removed successfully.According to the physician, the sheath damage was due to the adherences at femoral access from the previous evar at the level of femoral access.According to the gore® dryseal flex introducer sheath instructions for use (ifu), adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.

Manufacturer Narrative

H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The sheath will be provided for analysis.Further information will be provided.

Manufacturer Narrative

The investigation conclusion code was corrected from d1501 for d15.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Type of Device: 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18361747
• MDR Text Key: 330933036
• Report Number: 3007284313-2023-02958
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White