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

Catalog Number	2115
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "18fr manta valve resistance during closure after tavr case with edwards valve system which caused it to back out and affected the tip and anchor.There was no harm or consequence to the patient.".
Additional Manufacturer Narrative
(b)(4).No unit was returned for evaluation.The instructions-for-use (ifu) provided with this kit warns the user "if significant resistance is felt by inserting the bypass tube into the manta sheath, remove the entire system and open a new device." the details of the complaint were reviewed; the same manta was used to complete the case.No patient harm noted.A capa was previously initiated for bypass tube resistance that was attributed to a supplier manufacturing deficiency.Corrections were implemented.The complaint rate for bypass tube resistance is within occurrence limits as defined in capa, and further investigation related to this event will be initiated if the occurrence rate exceeds the limit.A device history record review was performed, and no relevant findings were identified.Based on the information, the most likely root cause of the issue is undeterminable.
Event or Problem Description
It was reported that "18fr manta valve resistance during closure after tavr case with edwards valve system which caused it to back out and affected the tip and anchor.There was no harm or consequence to the patient.".

• 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: 23254800
• Report Number: 3010252479-2025-00098
• Device Sequence Number: 21393625
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240501(17)251101(10)73E2400011(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73E2400011
• 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: 10/09/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2024
• 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: Male