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

Model Number	DSF2633
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It should be noted that, per the gore® dryseal flex introducer sheath instructions for use (ifu), the nominal outer body diameter of a 26fr gore® dryseal flex introducer sheath is 9.5mm.Additionally, the ifu states ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) 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.¿.
Event or Problem Description
The following information was reported to gore through the (b)(6) clinical study.On (b)(6) 2022, the patient underwent endovascular treatment of an aortic arch aneurysm (zone 0/1) using a 26fr gore® dryseal flex introducer sheath.During the procedure, bleeding from the access vessel on the right side and a decrease in blood pressure reportedly occurred when the gore® dryseal flex introducer sheath was removed from the puncture site.Blood loss measured a reported 2440ml.The cause of the rupture/disruption of the access vessel was not indicated although it was reported the event was related to the endovascular procedure.The right external iliac/femoral artery region measured 8mm in diameter, and it was unknown if the patient had any notable anatomic issues.According to the report, the patient¿s blood pressure recovered after intra-operative transfusion of red cell concentrate (8 units) and fresh frozen plasma (8 units).The patient tolerated the procedure.

• 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: 13548919
• Report Number: 3007284313-2022-01778
• Device Sequence Number: 5269254
• 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
• Report Date (Section B): 02/17/2022

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: 06/02/2023
• 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): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/17/2022
• Date Device Manufactured: 06/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male