MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GEM COUPLER MICROVASCULAR ANASTOMOTIC INSTRUMENT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	519303002010
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gem coupler microvascular anastomotic instrument presented an abnormal resistance ("slight snagging") prior to breast reconstruction surgery.The device was returned for lubrication and resterilization, and a second vein coupler was opened as a backup; both were available for use prior to surgery.During vein to vein anastomosis, neither instrument functioned as intended, as the user was unable to connect them to the disposable coupler components.The user remarked that there was "something wrong with the internal spring mechanism", and they could visually observe that something was obstructing it.Multiple disposable components were attempted without success.An older coupler instrument (anastomotic instrument) was subsequently used but demonstrated significant resistance.Although an anastomosis was achieved, an anastomotic leak was detected, requiring a new anastomosis.Due to vessel shortening, additional surgical intervention was required.Part of the rib had to be resected, during which a cut occurred and significant hemorrhage from the internal mammary artery happened.The surgeon clamped the "bleeding" preventing any major blood loss.During such compression the pleura got "torn" which results in a pneumothorax."gastro-intestinal surgery was called" and a chest drain was inserted; bleeding had been resolved.The vessels thrombosed twice, and the flap experienced prolonged ischemia time.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to h6.H11: 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: GEM COUPLER MICROVASCULAR ANASTOMOTIC INSTRUMENT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SAINT PAUL - MCA; 2575 university ave w.; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24947595
• Report Number: 1416980-2026-01409
• Device Sequence Number: 14762725
• Product Code: MDM
• UDI-Device Identifier: 00844735005233
• UDI-Public: (01)00844735005233
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 519303002010
• Device Catalogue Number: 519303002010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GEM COUPLER MICROVASCULAR ANASTOMOTIC INSTRUMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown