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

Model Number	DSF2265
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Stenosis (2263); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2023, this patient underwent endovascular treatment using gore® dryseal flex introducer sheath (dsf) and gore® tag® conformable thoracic stent graft with active control system for descending aortic aneurysm.It was reported that the patient's access vessel had many thrombosis and calcification prior to the procedure, and the lumen was narrow.When the dsf was inserted from the right femoral artery, there was considerable resistance.After removing the dsf, only the dilator was inserted, then the dsf was inserted again.The stent graft was deployed without reported issues, and the dsf was removed.Angiography confirmed the outflow of the contrast agent in the right external iliac artery.The rupture area was surgically repaired.The patient tolerated the procedure.Code 5400-c used to capture surgical repair of right external iliac artery.
Additional Manufacturer Narrative
H6: code b18: the device was discarded at the treating facility and was therefore not available for analysis.H6: code e2402: used to cover calcification.According to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to, vascular trauma.Do not attempt to advance or withdraw guidewire, catheter, or other device through the introducer sheath or dilator if resistance is felt.Use fluoroscopy to determine the cause.Continued advancement or retraction against resistance may result in major bleeding, vessel damage, serious injury to the patient, or damage to / breakage of the guidewire, catheter, or other device.Advance and remove sheath only under fluoroscopic guidance.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: code b14: the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and indicated the product met specifications and procedures.H6: code c19: the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and indicated the product met specifications and procedures.H6: code d12: according to the gore® dryseal flex sheath instructions for use, adverse events with may occur and/or require intervention including, but not limited to, vascular trauma.According to the gore® dryseal flex introducer sheath instructions for use, the ifu caution: do not continue advancement or retraction of the catheter or other device into or out of the sheath if there is resistance.Determine the cause of resistance before proceeding.Do not attempt to advance or withdraw guidewire, catheter, or other device through the introducer sheath or dilator if resistance is felt.Use fluoroscopy to determine the cause.Continued advancement or retraction against resistance may result in major bleeding, vessel damage, serious injury to the patient, or damage to / breakage of the guidewire, catheter, or other device.Advance and remove sheath only under fluoroscopic guidance.H6: code d1001: it was reported that the patient's access vessel had many thrombosis and calcification prior to the procedure, and the lumen was narrow.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17295008
• Report Number: 3007284313-2023-02612
• Device Sequence Number: 3864089
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: 08/23/2025
• Device Model Number: DSF2265
• Device Catalogue Number: DSF2265
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male