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

Catalog Number 515101400010

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

Patient Problem Injury (2348)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported a patient underwent a neck free flap surgery, in which a coupler device was used.Upon discharge, during removal of the gem wire, the surgeon pulled the wire until tension was felt and described the wire as feeling a bit ¿brittle¿ in their hands.Additional pressure was added to discharge the probe from the coupler, and the wire snapped ¿leaving some internally lodged¿.The remaining wire end at the break was retrieved with forceps and the rest was attempted to be extracted.An x-ray was performed which detected a remaining section of wire, including the probe tip itself.The surgeon ¿released a few stitches at bedside¿, and excised the wire and probe, then sutured again.The patient outcome was reported as the ¿doing fine.¿ no additional information is available.

Manufacturer Narrative

A device history review revealed no issues that could have caused or contributed to the reported issue.The device was not received for evaluation; therefore, a device analysis could not be completed.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: 10264636
• MDR Text Key: 198535964
• Report Number: 1416980-2020-03946
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): Y
• PMA/PMN Number: K143589
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 515101400010
• Device Lot Number: SP19F14-1379372
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention