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

Model Number DSF2233

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 06/07/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, this patient underwent an endovascular treatment for an impending rupture of the descending thoracic aorta using gore® tag® conformable thoracic stent grafts with active control system and a gore® dryseal flex introducer sheath (dsf, 22fr).The final angiography showed no problem in the access vessels.The patient tolerated the procedure.On (b)(6) 2022, follow-up examination showed a pseudoaneurysm formation in the right external iliac artery which was the access vessel of initial procedure.On the same day, a gore® viabahn® endoprosthesis (8 mm x 5 cm) was implanted in the right external iliac artery.The patient tolerated the procedure.Reportedly, the diameter of the right external iliac artery was narrow (5.7-6.4 mm).According to the gore® dryseal flex introducer sheath sizing guide, the nominal outer diameter of the 22fr sheath is 8.2 mm.

Manufacturer Narrative

H6: code 3331 and 213.

Manufacturer Narrative

Added d4, g3/g4, h1/h2, h4/h5, and h6.

• 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14875694
• MDR Text Key: 295051583
• Report Number: 3007284313-2022-02010
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630073
• UDI-Public: 00733132630073
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

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
• Device Operator: Health Professional
• Device Model Number: DSF2233
• Device Catalogue Number: DSF2233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 06/07/2022; 10/06/2022
• Supplement Dates FDA Received: 07/11/2022; 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female