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

Catalog Number DSL2428

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device is currently in progress.According to the gore® dryseal sheath instructions for use, adverse events that may occur and / or require intervention include, but are not limited to bleeding and vascular trauma.

Event Description

On (b)(6) 2017 a patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm related to chronic type b dissection etiology, with a conformable gore® tag® thoracic endoprosthesis.Access was obtained from the left femoral artery with a cut down.A 24 fr gore® dryseal sheath was prepped per ifu and utilized, despite the point made by the fsa that the vessel size appeared to be small to accommodate this sheath.A left ilio and femoral artery rupture was recognized following sheath removal.This was treated by means of an ilio to femoral bypass (external iliac to common femoral) utilizing a 10mm dacron graft.The physician made no claim that the sheath contributed to the rupture.During the procedure the patient experienced blood loss of 8,000cc.The patient was given 13 units of packed red blood cells, 500cc platelets and 2250cc fresh frozen plasma.The patient tolerated the procedure.

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.

• Brand Name: GORE® DRYSEAL SHEATH
• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6429660
• MDR Text Key: 70712061
• Report Number: 3007284313-2017-00062
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2019
• Device Catalogue Number: DSL2428
• Device Lot Number: 15797580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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; Life Threatening; Other; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 83