MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLOW COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number ASKU

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

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The event occurred on an unspecified date "sometime" in (b)(6) or early (b)(6) 2021.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.

Event Description

It was reported that a patient underwent a free flap breast reconstruction in which an unknown coupler device was used.Approximately three to four days post-removal of the lead wire ¿where it had been snipped at the skin level¿, the patient began to experience discomfort (no further details).As a result, the patient was scheduled to undergo a surgery on four days after receipt of this report to have the lead wire removed surgically.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

It was confirmed by the manufacturer of the wire used in the manufacturing of the flow coupler probe, there is no nickel used in any portion of the wire that is used to produce the flow coupler probe.It is unlikely that the patient reaction was due to the flow coupler wire (that was clipped at the skin leaving the remainder of the wire and probe in the skin/tissue of the patient).The instructions for use clearly indicates that the wire needs to be pulled out or surgically removed following discontinued use of the flow monitor.This would indicate that clipping the wire at the skin is an off-label usage of the flow coupler device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: FLOW COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11436192
• MDR Text Key: 238369862
• Report Number: 1416980-2021-01103
• Device Sequence Number: 1
• Product Code: MVR
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 03/28/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention