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

Catalog Number	519600001061
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9506240
• Report Number: 1416980-2019-07082
• Device Sequence Number: 14198599
• Product Code: MVR
• UDI-Device Identifier: 00844735006179
• UDI-Public: 00844735006179
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 519600001061
• Device Lot Number: SP19F25-1381499
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other