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

Catalog Number 519600001061

Device Problem Break (1069)

Patient Problems Intimal Dissection (1333); No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a bilateral diep (deep inferior epigastric perforators) procedure the ring of the flow coupler slipped.It was further reported "during attempt to use the everter accessory and coupler to anastomose the ima artery on the first breast, the coupler ring slipped".There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional corrected information: during the bilateral diep procedure, the user attempted to use the everter system and coupler to anastomose the internal mammary artery in the first breast case and the coupler ring slipped.While reseating the ring in the wing jaw assembly, the intimal began to split 1-2mm and there was not enough artery length left to perform the anastomosis using the coupler, and hence the vessel was sutured.At the time of this report, the patient had recovered.

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: 9489340
• MDR Text Key: 171855152
• Report Number: 1416980-2019-06980
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519600001061
• Device Lot Number: SP19F25-1381499
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other