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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during an evar.Bleeding on the surface after manta deployment.Cutdown performed with explant of manta.Manta footplate was stuck in small side branch not appreciated during u/s.Collagen was pushed in the vessel causing occlusion of cfa.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).The complaint of manta occlusion was able to be confirmed through review of the customer report, supplied photo, and additional information.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.The details of the complaint were reviewed.The procedure performed was an endovascular aneurysm repair (evar) via right common femoral artery (cfa) access.A gore 16f dryseal sheath was used.Ultrasound-guided micropuncture access was obtained at the mid femoral head on the first attempt.The vessel diameter measured 8 mm.Moderate posterior calcification was noted, with no tortuosity.The measured vessel depth was 6.5 cm, and the manta closure device was deployed at the measured depth.No issues were reported with advancing or withdrawing the procedure sheaths.Heparin ivp and protamine ivp were administered.Hemostasis was not achieved.A surgical cutdown was performed with explant of the manta device.During cutdown, the manta footplate was found to be lodged in a small side branch not appreciated on ultrasound, and the collagen plug was noted to be within the vessel, resulting in cfa occlusion.Manual pressure was held for approximately 25 minutes.The patient experienced no harm or lasting health consequences and was stable post-procedure.Based on the customer report that the manta footplate was stuck in a small side branch not appreciated during ultrasound, the probable cause is unintentional use error.
Event or Problem Description
It was reported that "during an evar.Bleeding on the surface after manta deployment.Cutdown performed with explant of manta.Manta footplate was stuck in small side branch not appreciated during u/s.Collagen was pushed in the vessel causing occlusion of cfa.The patient was reported as fine post the procedure.".

• Brand Name: MANTA 18F
• Common Device Name: 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: 24017760
• Report Number: 3010252479-2025-00120
• Device Sequence Number: 21132570
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)250110(17)260710(10)73A2500358(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/17/2025

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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/10/2026
• 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