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
Qn# (b)(4).
Event or Problem Description
It was reported that: "first manta device was introduced into manta sheath valve with increased resistance which caused it to back out and affected the tip and anchor.Another device (second manta) was opened and introduced into the same sheath with same resistance, but bypass tube went in and was held in place with operator's thumb while advancing the manta device fully into clicked position.From there the manta worked as it should and a good close was noted.This complaint is for the second manta.Associated complaint 3010252479-2025-00098.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint details were reviewed.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.".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: "first manta device was introduced into manta sheath valve with increased resistance which caused it to back out and affected the tip and anchor.Another device (second manta) was opened and introduced into the same sheath with same resistance, but bypass tube went in and was held in place with operator's thumb while advancing the manta device fully into clicked position.From there the manta worked as it should and a good close was noted.This complaint is for the second manta.Associated complaint (b)(4).

• 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: 23263940
• Report Number: 3010252479-2025-00105
• Device Sequence Number: 5178793
• 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: 10/10/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 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: Unknown