MAUDE Adverse Event Report: BAXTER HEALTHCARE - SAINT PAUL GEM MICROVASCULAR ANASTOMOTIC COUPLER

Model Number GEM 2753

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a 2.5mm gem coupler would not anastomose the vessel completely.The backup 2.5mm coupler was opened and implanted successfully.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Too much tissue in the ring and/or surgeon does not pinch assembly together with a hemostat is the most likely cause of the event not closing properly.The occurrence rate of not closing properly is low and meets the anticipated rate in the risk file.There was no harm to the patient.No additional action will be taken.Future events will be monitored.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GEM MICROVASCULAR ANASTOMOTIC COUPLER
• Type of Device: ANASTOMOTIC COUPLER
• Manufacturer (Section D): BAXTER HEALTHCARE - SAINT PAUL; saint paul MN
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7573522
• MDR Text Key: 110368218
• Report Number: 1416980-2018-03438
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GEM 2753
• Device Catalogue Number: 5111-00250-060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2018
• 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: Initial
• Patient Sequence Number: 1