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

Model Number DSF2433

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

Patient Problem Rupture (2208)

Event Date 12/07/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment of a thoracic aorta aneurysm using gore® tag® conformable thoracic stent graft with active control system.A 24fr gore® dryseal flex introducer sheath was used for access.The 24fr sheath was inserted from right femoral artery.A confirmation angiography imaging revealed rupture of the right external iliac artery.Two stent grafts were placed to treat the rupture.It was reported that the right external artery diameter was approximately 7.3mm where the rupture occurred.The outside diameter of the 24fr sheath is 8.2 mm.

Manufacturer Narrative

It was reported that the right external artery diameter was approximately 7.3mm where the rupture occurred.The outside diameter of the 24fr sheath is 8.2 mm.According to the gore® dryseal flex introducer sheath, if vessel access is not adequate, serious injury, including vessel rupture, bleeding and death may result.

Manufacturer Narrative

H6: investigation finding and conclusion codes.

• 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: 13096215
• MDR Text Key: 288182381
• Report Number: 3007284313-2021-01724
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630950
• UDI-Public: 00733132630950
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DSF2433
• Device Catalogue Number: DSF2433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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: 84 YR
• Patient Sex: Female