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

Model Number DSF1233

Device Problem Break (1069)

Patient Problem Rupture (2208)

Event Date 12/13/2021

Event Type  Injury  

Event Description

On unknown date, a patient underwent endovascular treatment for an abdominal aortic aneurysm and a right common iliac artery aneurysm using gore® excluder® aaa endoprostheses and a gore® 12fr dryseal sheath as an accessory.On unknown date, an enlargement of distal side of the right common iliac artery aneurysm and thrombus in the aortic extender component that was implanted in the right common iliac artery were observed.On (b)(6) 2021, a reintervention to treat the enlargement of the common iliac artery aneurysm was performed (this was reported on mfr report #2017233-2022-02665).During insertion of a 12fr gore® dryseal flex introducer sheath, strong resistance was felt.Only the dilator was inserted, then after some attempts, the sheath was able to be inserted.The right internal iliac artery was embolized using coil.Two stent grafts were implanted from the contralateral leg gate of the trunk-ipsilateral leg endoprosthesis to right external iliac artery.A sg balloon (non-gore) was used to touch-up; however, the balloon was ruptured.An attempt was made to remove the sg balloon however strong resistance was felt during retraction of the balloon at the distal end of the sheath.As an additional attempt was made to remove the sg balloon and the sheath together, approximately 1 cm of the distal end of the sheath split off and remained in the vessel.The sg balloon and the sheath were removed.A wire that was a part of the sheath was observed around the ruptured balloon.The wire was thought to be possibly connected to the sheath tip.The physician attempted to pull off the wire to remove the sheath tip, however this was unsuccessful.Then an unsuccessful attempt was made to remove the sheath tip using a catheter.The sheath tip was then removed surgically.During the surgical treatment, the right external iliac artery was damaged and stent graft (vbx) was implanted.Touch up was performed using another gore® 12fr dryseal sheath and a gore® molding & occlusion balloon catheter without any strong resistance.The patient tolerated the procedure.The physician stated as follows.The resistance and stress during insertion may have weakened the sheath tip, and the sheath tip may have deformed and crushed when the balloon was attempted to be removed.It appeared that the crushed portion of the sheath tip could not pass through the vessel wall when the sheath was removed and was split off at the weakened tip.The patient had previously undergone evar, and the area around the vessel was scarred after healing.The breakage of the sheath tip was probably due to the axial torsional force applied to the sheath in attempts to insert and remove it while resistance was felt.

Manufacturer Narrative

H6: investigation findings and investigation conclusion codes code 213: the review of the manufacturing records for the device verified the lot met all pre-release specifications.Code 3252: the device evaluation found that the sheath tip had been broken off from the rest of the device.Wire was exposed from the sheath.The root cause of the separation of the sheath tip could not be determined with the available information.

• 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: 13252616
• MDR Text Key: 288054361
• Report Number: 3007284313-2022-01748
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132629961
• UDI-Public: 00733132629961
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: DSF1233
• Device Catalogue Number: DSF1233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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 Sex: Male