MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLO-THRU; CLAMP, VASCULAR

Catalog Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A survey reported that while using a flo-thru intraluminal shunt during coronary artery procedures to channel intravascular blood through a vascular anastomosis (to provide a temporary blood free operative field), a moderate risk of damage to blood vessel further described as ¿blunt injury to blood vessels¿ was noted.No additional information is available.

Manufacturer Narrative

B5: report 1416980-2020-04147 was submitted in error.A survey was sent to healthcare providers to compare the product attributes for the indication of flo-thru devices with other similar products.There was no event reported involving a patient with the flo-thru device.

• Brand Name: FLO-THRU
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10302856
• MDR Text Key: 199709437
• Report Number: 1416980-2020-04147
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other