MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF1833

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Vascular Dissection (3160)

Event Date 03/08/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment for an abdominal aortic aneurysm.After the physician removed the sheath, a localized dissection was observed in the access vessel.To treat the dissection, a bare metal stent was implanted.The patient tolerated the procedure.It was reported that the physician did not feel particular resistance when inserting the sheath, but the access vessels were narrow, so the dissection was within expectation.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8484196
• MDR Text Key: 140951256
• Report Number: 3007284313-2019-00096
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K160254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2021
• Device Catalogue Number: DSF1833
• Device Lot Number: 18387464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR