MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER

Catalog Number DSF2433

Device Problem Off-Label Use (1494)

Patient Problem Perforation of Vessels (2135)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the gore® dryseal flex introducer sheath instructions for use, the nominal body outer diameter of a 24fr sheath is 8.8mm.The ifu states ¿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) 2018, a 24fr gore® dryseal flex introducer sheath was used as part of a thoracic endovascular aortic repair.According to the report, resistance was felt in the left femoral artery (measuring 5.6 mm - 5.9 mm in diameter), and the sheath could not be advanced.The physician dilated the left femoral and left external iliac arteries with a balloon, and the sheath was successfully advanced to the intended position.After two endoprostheses were advanced and implanted, the sheath was removed from the patient.Upon withdrawal, it reportedly appeared that the left femoral artery was damaged near the sheath insertion site.No decrease in blood pressure was observed.The lesion in the left femoral artery was surgically repaired, and the patient tolerated the procedure.

• Brand Name: AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0)
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: damon jackson ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8228449
• MDR Text Key: 132429054
• Report Number: 3007284313-2019-00009
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Catalogue Number: DSF2433
• Device Lot Number: 18433978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 87 YR