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

Model Number DSF2233

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation of Vessels (2135)

Event Date 10/27/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient underwent endovascular treatment of thoracic aneurysm enlargement using a gore® tag® conformable thoracic stent graft with active control system.During the procedure, a 22fr gore® dryseal flex introducer sheath was inserted from the left femoral artery.According to the report, resistance was felt while advancing the sheath.The reason for the resistance felt while advancing the sheath was unknown.The diameter of the access vessel from the left femoral artery to the external iliac artery measured a reported 6.1mm to 8.2mm.After all gore® tag® devices were implanted, the left external iliac artery was reportedly ruptured upon removal of the sheath.The area of sheath insertion was surgically repaired.The patient tolerated the procedure.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded at the facility and, therefore, was not available for direct analysis by gore.It should be noted that, per the gore® dryseal flex introducer sheath instructions for use (ifu), the nominal body outer diameter of a 22fr gore® dryseal flex introducer sheath is 8.2mm.The diameter of the access vessel from the left femoral artery to the external iliac artery in this case measured a reported 6.1mm to 8.2mm.The ifu states ¿adequate vessel access is required to introduce the sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.¿ additionally, per ifu, if vessel size is smaller than the nominal body outer diameter, major bleeding, vessel damage, or serious injury to the patient, including death, may result.

• 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12853181
• MDR Text Key: 284469305
• Report Number: 3007284313-2021-01672
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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
• Date Manufacturer Received: 10/27/2021
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female