MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GEM Microvascular Anastomotic COUPLER; Device,anastomotic,microvascular

Model Number	GEM2753
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ring of a gem coupler,2.5mm had opened.This occurred after a bilateral deep inferior epigastric perforator (diep) breast reconstruction procedure.Postoperative monitoring identified right breast swelling and lack of flap flow.The patient was returned to the operating room for re-examination and confirmation of flap failure.During the re-examination, the right sided coupler was observed to be open.The physician reported that the diep vein had separated from the internal mammary vein (imv) at the coupler site; however, the cause of the separation could not be determined.Attempts to recover the flap were unsuccessful.The reporting surgeon stated that the observed irreparable damage to the internal mammary vein suggested an avulsion mechanism rather than an intrinsic defect in the coupler itself.No additional information is available.
Additional Manufacturer Narrative
D4 udi: the expiration date is unknown; therefore, the udi will consist of the di and the lot #.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GEM Microvascular Anastomotic COUPLER
• Common Device Name: Device,anastomotic,microvascular
• 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 ; +1(224)270-5355
• MDR Report Key: 50024851
• Report Number: 1416980-2026-02437
• Device Sequence Number: 10551492
• Product Code: MVR
• UDI-Device Identifier: 00844735002669
• UDI-Public: (01)00844735002669(10)SP25E07-2274179
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

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: GEM2753
• Device Catalogue Number: 511100250060
• Device Lot Number: SP25E07-2274179
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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,2.0MM,6PK
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown