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

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

It was reported from an anonymous survey result that the risk to vessel wall damage with the use of a flo-thru intraluminal shunt when used to channel (shunt) intravascular blood through a vascular anastomosis to provide a temporary blood free operative field, during peripheral vascular procedures was rated as moderate.The physician reported ¿the risk i have seen of this complication is present in many cases¿.No further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.

Manufacturer Narrative

Additional information: h6 and h10.The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.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: 10350262
• MDR Text Key: 201351368
• Report Number: 1416980-2020-04578
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other