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

Catalog Number	515101200010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during anastomosis using two coupler units, there was a ring dislodgement and the rings were found not to be aligned.After integrating the first probe to the applicator, it became detached.This happened before patient use.A second probe was successfully attached and the vessel ends were pulled through the coupler and both rings were joined, however, after completing the anastomosis, the surgeon realized it was "not well made" and there was a massive leak possibly due to the ¿rings were not well adapted¿.It was reported that the surgeon "cut the vessel" and performed a manual anastomosis.The patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection showed the approximated rings to be visibly and physically aligned, and the probe was integrated into the flow coupler ring.The approximated rings showed some manipulation marks on the pin side of both rings which could have contributed to the leak that appeared post-approximation.The reported condition was verified.If the rings are not fully closed during the surgical process (using a surgical instrument; forceps, hemostat etc.), it is possible that a leak could occur.The cause of the condition could not be determined.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.
Additional Manufacturer Narrative
B5: the ring dislodgement that occurred prior to use was captured in mdr report#: 1416980-2020-06441.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: 10687079
• Report Number: 1416980-2020-06440
• Device Sequence Number: 3208822
• Product Code: MVR
• UDI-Device Identifier: 00844735005998
• UDI-Public: 00844735005998
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K132727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 515101200010
• Device Lot Number: SP18I25-1326306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/13/2020; 06/23/2021
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/18/2020; 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Required Intervention