MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES, INC. GORE-TEX STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Lot Number 23501869

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

Gore-tex vascular stretch graft size 18 ref sa1802 for procedure.An approx 2mm size piece of hair noticed by scrub and circulator found on graft upon opening from the sterile package on the sterile field.

• Brand Name: GORE-TEX STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES, INC.
• MDR Report Key: 12985125
• MDR Text Key: 282266035
• Report Number: MW5105972
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 23501869
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR