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

Catalog Number DSF1633

Device Problems Unintended Ejection (1234); Device Slipped (1584)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  Injury  

Manufacturer Narrative

D10: gore® dryseal flex introducer sheath dsf1233 and gore® excluder® conformable aaa endoprosthesis.H3: the device has been discarded at the facility, no product evaluation can be performed.H6: g07002 used for introducer sheath.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported that on (b)(6) 2023, a patient presenting with an aortic ulcer was treated with a gore® excluder® conformable aaa endoprosthesis with active control system.The trunk ipsilateral leg was introduced and implanted from the right after a dissection on the left side caused by the wire and the gore® dryseal flex introducer sheath (dsf).The sheath being used to implant the device on the right side ultimately slipped out and access was lost.Dsf1233 (b)(6) was used on the patient¿s left side, and dsf1633 (b)(6) was used on the right side.The patient was converted to open surgery and the device was explanted.The patient tolerated the procedure.

Manufacturer Narrative

Emdr section h6 codes updated to reflect results of investigation.

Manufacturer Narrative

Correction of b1: the initially submitted event type of a serious injury and product malfunction is incorrect.The presented event is only considered a serious injury, not a reportable product malfunction.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17994991
• MDR Text Key: 326370771
• Report Number: 3007284313-2023-02850
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00733132630028
• UDI-Public: 00733132630028
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DSF1633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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
• Treatment: GORE® DRYSEAL FLEX INTRODUCER SHEATH DSF1233.
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male