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

Model Number DSF1433

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rupture (2208); Vascular Dissection (3160)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment using gore® dryseal flex introducer sheath (dsf) for the left common iliac aneurysm.Reportedly, the patient's left external iliac artery was highly tortuous.When the guide wire was inserted, it was reported that the tortuous part became loop shape.The 14fr dfs was inserted from the left access.The dfs was advanced without resistance, but the loop was not resolved.The guide wire was replaced, but it was not successful.The dfs was pulled to right before the loop, and an attempt was made to resolve the loop shape.Then, blood pressure dropped.At that time, the guide wire was removed when the dsf was pulled.Angiography revealed access vessel damage.An attempt was made to cross wire, but it was unsuccessful.It was determined to convert the procedure to aorto-uni-iliac (aui).After deployment the stent graft, the nbca was injected into the left common iliac aneurysm sac.During femoral-femoral artery bypass, rupture of the left external iliac artery was confirmed.The proximal and distal sides of the external iliac artery were ligated.The patient tolerated the procedure.

Manufacturer Narrative

H6: updated investigation findings and conclusions.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13058140
• MDR Text Key: 285844325
• Report Number: 3007284313-2021-01716
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: 00733132630004
• 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
• Report Date: 06/10/2022

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 Expiration Date: 04/13/2023
• Device Model Number: DSF1433
• Device Catalogue Number: DSF1433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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: 88 YR
• Patient Sex: Male