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 11/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state ¿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.

Event Description

On (b)(6) 2021, the patient underwent endovascular treatment of a thoracic aneurysm using a 22fr gore® dryseal flex introducer sheath (nominal body outer diameter: 8.2mm) as an accessory during the procedure.The right access vessel measured a reported 6-7 mm in diameter, and there reportedly was stenosis in the right external iliac artery.Percutaneous transluminal angioplasty was performed with an 8 mm balloon before sheath insertion.During insertion of the 22fr sheath, resistance was reportedly felt at the right external iliac artery.The sheath was removed once and reinserted successfully.After stent graft implantation, access angiography reportedly showed vessel damage in the right external iliac artery.Two additional stent grafts were implanted to treat the damaged vessel.According to the report, a dissection was also observed in the common iliac artery (no further details regarding the dissection were available).The physician opted to take a wait-and-watch approach regarding the dissection, and the procedure was completed.The patient tolerated the procedure.

Manufacturer Narrative

Added g3/g4 with pma/510k number added h1/h2 and h6 conclusion code.

• 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: 12961356
• MDR Text Key: 281923971
• Report Number: 3007284313-2021-01697
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• 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: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female