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	Vascular Dissection (3160)
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 and ultrasound were utilized to gain access in the left common femoral artery at the bottom of the femoral head.Moderate posterior calcification was reported.Measured depth for the manta was 4.5 cm.Systolic blood pressure was 120/55 and act was 565.Heparin 7000units and 40 mg of protamine were administered during the procedure.It was reported there was a tract deployment.Dr pulled hard and fast to red.Lots of extravasation on post angio.Lock far away from vessel.After multiple balloon inflations at lt cfa extravasation continued and vascular was called to do a cutdown.There was no patient harm from the incident.".
Event or Problem Description
It was reported that: "during a tavr procedure.Micro puncture and ultrasound were utilized to gain access in the left common femoral artery at the bottom of the femoral head.Moderate posterior calcification was reported.Measured depth for the manta was 4.5 cm.Systolic blood pressure was 120/55 and act was 565.Heparin 7000units and 40 mg of protamine were administered during the procedure.It was reported there was a tract deployment.Dr pulled hard and fast to red.Lots of extravasation on post angio.Lock far away from vessel.After multiple balloon inflations at lt cfa extravasation continued and vascular was called to do a cutdown.There was no patient harm from the incident.".
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 was left common femoral artery.Moderate posterior calcification noted.The measured depth was 4.5 cm.Manta was deployed at the measured depth.Tension gauge went hard and fast to red.The ifu states the following: do not pull past green.Excessive force may cause vessel damage.Only light tension (yellow/green) is required.A device history record (dhr) was reviewed; no issue related to complaint was noted.Slow leak was noted.Angiogram pictures shared confirm the lock to be away from the vessel.Extravasation was also noted.Manual pressure and pta ballooning were employed.Hemostasis was not achieved.Subsequently, surgical cutdown was down to explant the manta and repair the vessel.Patient condition is fine.Based on the information, the most likely root cause of the issue user error.

• 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: 23298561
• Report Number: 3010252479-2025-00101
• Device Sequence Number: 15932045
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)250110(17)260710(10)73A2500358(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2026
• Device Catalogue Number: 2115
• Device Lot Number: 73A2500358
• 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: 10/15/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2025
• 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: NOT REPORTED; NOT REPORTED.
• Patient Sex: Unknown