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

Model Number	EN240
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/16/2026
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: approximately 5-10 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: preoperative ct insertion direction of the device: it was inserted anterogradely in the long-axis view.Investigation will be performed on the incriminated device, as soon as the device isreturned to the manufacturer.
Event or Problem Description
It was reported that after enclose2 was inserted into the aorta and a punch-out was performed, brisk bleeding occurred, prompting discontinuation of its use.When attempts were made to withdraw the device by turning the upper jaw and lower jaw dials, it could not be removed.After several additional attempts, it was finally able to be withdrawn.After insertion of the subject device and completion of the punch-out, bleeding became uncontrollable.A decision was made to temporarily withdraw the device; however, the lower jaw dial did not rotate smoothly, and it took time to fully close the lower jaw, resulting in difficulty withdrawing the device.The device was ultimately withdrawn without incident, and the procedure was completed successfully using another enclose ii device.Hemostasis was checked using the extension tube, and no problems were observed.Although there was difficulty in removing the product, there was no damage to the aorta.The physician stated that there were no problems during the scalpel incision or when using the puncher.No particular information has been obtained regarding the patient's outcome.The physician has used this product in approximately 10 cases.

• 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: 25095035
• Report Number: 3002539629-2026-00002
• Device Sequence Number: 18639599
• Product Code: DXC
• UDI-Device Identifier: 00852621004192
• UDI-Public: 00852621004192
• 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): Unknown
• 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: EN240
• Device Lot Number: 2025041274239
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• 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