MAUDE Adverse Event Report: VITALITEC INTERNATIONAL INC ENCLOSE II ANASTOMOSIS ASSIST DEVICE; VASCULAR CLAMP

Model Number	EN235
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer was notified of this incident in japan by century medical inc., distributor of enclose ii in japan.Additional information provided by the healthcare facility on this incident: procedure: off-pump coronary artery bypass (opcab) ; user experience: more than 11 uses ; defect occurrence status: during product use (after insertion into the aorta) at which site faults have occurred: first site nature of the aorta: no findings methods for confirming the nature of the aorta: unknown insertion direction of the device: long-axis direction.Check of the user before use: no issue found.Incrimintaed device not yet returned to the manufacturer.Investigation will be performed on the incriminated device once the device is available.
Event or Problem Description
It was reported that a device malfunction occurred during the use of enclose ii.No harm to the patient or other adverse health effects were reported.After insertion of enclose ii into the aorta, both the upper jaw and lower jaw were deployed; however, adequate hemostasis could not be achieved.Upon removal of enclose from the aorta, it was confirmed that there was a hole in the membrane.Use of enclose was discontinued, and the procedure was continued with a partial clamp.No patient injury or other adverse health effects were reported.

• Brand Name: ENCLOSE II ANASTOMOSIS ASSIST DEVICE
• Common Device Name: VASCULAR CLAMP
• Manufacturer (Section D): VITALITEC INTERNATIONAL INC; 10 cordage park cir suite 100; plymouth MA 02360
• Manufacturer Contact: sebastien guillo ; 10 cordage park circle; suite 100; plymouth, MA 02360
• MDR Report Key: 25093051
• Report Number: 3002539629-2026-00001
• Device Sequence Number: 5078849
• Product Code: DXC
• UDI-Device Identifier: 00852621004185
• UDI-Public: 00852621004185
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EN235
• Device Lot Number: 2025041274239
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown