MAUDE Adverse Event Report: BAXTER BIOSCIENCE VASCU-GUARD VASCULAR PATCH

Catalog Number VG-0106N

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Respiratory Distress (2045)

Event Date 01/25/2016

Event Type  Injury  

Event Description

Vascu-guard provider letter regarding risk of bleeding dated (b)(6) 2016 reviewed with provider, dr (b)(6).Dr (b)(6) responded that this surgery in (b)(6) of 2016 involved oozing from the patch resulting in the neck hematoma.Pt required a return to operating room.

• Brand Name: VASCU-GUARD VASCULAR PATCH
• Type of Device: VASCULAR PATCH
• Manufacturer (Section D): BAXTER BIOSCIENCE
• MDR Report Key: 6132865
• MDR Text Key: 61104486
• Report Number: 6132865
• Device Sequence Number: 1
• Product Code: DXZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Catalogue Number: VG-0106N
• Device Lot Number: SP15J23-1090804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/26/2016
• Device Age: NA
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 60