MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL - MCA COUPLER; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number 511100200060

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent surgery in which a 2.0mm coupler device was used for a venous anastomosis on brachial ante free flap.It was reported the anastomosis was difficult to perform as the coupler ¿was a little seized and the tightening has been made difficult¿.The anastomosis was discontinued ¿a few seconds later, and it was then necessary to repair it with wire¿.No further details were provided regarding medical interventions or patient outcome.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SAINT PAUL - MCA; saint paul MN
• MDR Report Key: 8488421
• MDR Text Key: 141087608
• Report Number: 1416980-2019-01828
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 511100200060
• Device Lot Number: SP17B06-1212234
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention