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

Catalog Number 519600001061

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

Patient Problem Injury (2348)

Event Date 11/18/2019

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 bilateral diep (deep inferior epigastric perforators) procedure, in which coupler devices were used.It was reported that on the first breast, during eversion of vessel, the ring was pushed out of the wing jaw assembly.The coupler system was abandoned, and the vessel was anatomized with suture.On the second breast, a 2.0mm coupler was used with approximated 2.5mm internal mammary artery and 2.0mm flap vessel, both were everted and closed with the coupler system.No thrombi were observed, however, the surgeon reported a whitening of tissue and darkening of veins.It was reported a side branch was opened and no blood flow was observed.The coupler devices were removed, and the vessels were re-anatomized with suture.The patient outcome was reported as ¿fine¿.No additional information is available.

Manufacturer Narrative

Additional information: the device was not received for evaluation; therefore, a device analysis could not be completed.A device history review revealed no issues that could have caused or contributed to the reported issue.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
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9506240
• MDR Text Key: 172430780
• Report Number: 1416980-2019-07082
• Device Sequence Number: 1
• Product Code: MVR
• UDI-Device Identifier: 00844735006179
• UDI-Public: 00844735006179
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 519600001061
• Device Lot Number: SP19F25-1381499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other