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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during a tevar procedure, an 18 fr manta was deployed in rt femoral artery but failed to close.Dr.(b)(6) held pressure for 10minutes, preformed doppler study to confirm lack of blood flow past the closure site.A successful cut down procedure was preformed to close artery & remove anchor and collagen.The patient was reported as fine.".
Event or Problem Description
It was reported that: "during a tevar procedure an 18 fr manta was deployed in rt femoral artery but failed to close.Dr.(b)(6) held pressure for 10minutes, preformed doppler study to confirm lack of blood flow past the closure site.A successful cut down procedure was preformed to close artery & remove anchor and collagen.The patient was reported as fine.".
Additional Manufacturer Narrative
(b)(4) the complaint of manta occlusion could not be confirmed through review of the customer report.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.There was no harm or health consequence for the patient.No movement of the patient or access site during recovery.An advantage glide guidewire was used to deploy the manta.The manta was reported to be positioned correctly in the vessel.The artery access location was the right common femoral artery (cfa).The vessel size was 8.5-9.0mm.Access was gained with a micropuncture kit, ultrasound was used, and only one attempt was needed.The access location of cfa was high.Mild calcification at iliac bifurcation, not at stick site, was noted.No tortuosity was noted.The measured depth for manta was 4+1.The manta was deployed at this depth.No issues with advancing or withdrawing procedure sheaths.Heparin ivp and protamine ivp were given.Hemostasis was not achieved and a cutdown was performed.The manta device was explanted during the cutdown.It's possible the high location of the access site could have contributed to the initial failure to close.Based on the customer report the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: 18F MANTA VASCULAR CLOSURE DEVICE
• Common Device Name: MANTA VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton PA
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton PA 19341
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24128645
• Report Number: 3010252479-2026-00002
• Device Sequence Number: 10394559
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)250325(17)260925(10)73C2500948(21)
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2026
• Device Catalogue Number: 2115
• Device Lot Number: 73C2500948
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2025
• 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