MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 18F; VASCULAR CLOSURE DEVICE

Catalog Number	2115
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during a tavr procedure.Micro puncture was utilised to gain accessphysician didn't complete taking the blue lever back to release the footplate and ended up having the footplate and collagen deploy in the skin tract.Physician went up and over with a balloon and covered stent to complete closure.The physician decided to give a blood transfusion in the room due to blood loss and to make sure that the patient was stable.".
Additional Manufacturer Narrative
(b)(4).Complaint details were reviewed.No unit was returned for evaluation.As per the additional information received, procedure was a tavr.Access site location and anatomical factors are unknown.The measured depth was not provided.The lever of the manta was not actuated fully.This led to the anchor not getting caught on the vessel wall and subsequently resulted in tract deployment.No angiograms or videos were provided.The ifu states the following: deploy device and seal puncture - hold the manta handle in the right hand at a 45-degree angle to the leg.While grasping the proximal handle end of the manta closure with the right hand, completely actuate the lever arm in the clockwise/ proximal direction.This deploys and releases the anchor within the vessel covered stent was used to seal the vessel.A device history record (dhr) was reviewed; no issue related to complaint was noted.Blood transfusion was done.Patient condition is fine and stable.Based on the information, the most likely root cause of the issue unintended use error.
Event or Problem Description
It was reported that: "during a tavr procedure.Micro puncture was utilised to gain accessphysician didn't complete taking the blue lever back to release the footplate and ended up having the footplate and collagen deploy in the skin tract.Physician went up and over with a balloon and covered stent to complete closure.The physician decided to give a blood transfusion in the room due to blood loss and to make sure that the patient was stable.".

• Brand Name: MANTA 18F
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23263860
• Report Number: 3010252479-2025-00102
• Device Sequence Number: 10146260
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240611(17)251211(10)73F2400402(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73F2400402
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2024
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown