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

Model Number	DSF1433
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During aorta iliac mechanical thrombectomy a dryseal flexsheath device was introduced to patient's right femoral artery.During manipulation sheath broke inside patient's artery.Fda safety report id# (b)(4).

• Brand Name: GORE DRYSEAL FLEX INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES, INC.
• MDR Report Key: 15249604
• Report Number: MW5111554
• Device Sequence Number: 20303530
• Product Code: DYB
• UDI-Device Identifier: 00733132630004
• UDI-Public: (01)00733132630004
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2024
• Device Model Number: DSF1433
• Device Catalogue Number: DSF1433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American