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 plaque disruption, further described as ¿placement of shunt into an irregularly shaped plaque can disrupt it especially if pushed into vessel roughly.¿ no additional information is available.

Manufacturer Narrative

Corrected event added to b5 b5: report 1416980-2020-04157 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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: FLO-THRU
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10304145
• MDR Text Key: 199844924
• Report Number: 1416980-2020-04157
• 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: 08/03/2020

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: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other