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 06/02/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, this patient underwent an endovascular treatment of a thoracic aortic aneurysm using gore® tag® conformable thoracic stent graft with active control system.A gore® dryseal flex introducer sheath (24fr) was inserted from the right femoral artery without any resistance.After the stent graft was implanted, when the sheath was removed, the blood pressure decreased and right external iliac artery rupture was observed.A gore® excluder® aaa endoprosthesis contralateral leg component was implanted from the common iliac artery to the external iliac artery.Blood pressure was recovered.The blood flow of the internal iliac artery was preserved.The physician stated there was no resistance when the sheath was inserted.Reportedly, the patient access vessel was 9 mm, but it was stenotic.

Manufacturer Narrative

H6: code 3331, 213.

• 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: 14875541
• MDR Text Key: 295048259
• Report Number: 3007284313-2022-02007
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: DSF2433
• Device Catalogue Number: DSF2433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• 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: 77 YR
• Patient Sex: Male