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

Catalog Number	2115NE
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi will be provided with the follow up report.
Event or Problem Description
It was reported that: "tavi procedure, the membrane of the manta sheath was stiff, and the manta catheter couldn't penetrate it.The doctor had to take new device, and that was ok." anatomical insertion site of device: right femoral artery.Device removed and a new manta kit was used.Therapy delayed due to this but not harm to the patient.".
Additional Manufacturer Narrative
Qn#(b)(4).One unit of manta and sheath were returned for evaluation.Blood particulates were noted on the unit.Unit was decontaminated and in spected.Minor tear was observed on the button valve.The unit was functionally tested for advancement.The bypass tube passed through the valve but dismantled a piece of the button valve within the lumen of the sheath.No significant resistance was noted.The device lot history record review for lot number mn2401578 manta 18f ce indicated no non-conformities related to this lot, therefore supporting the device met material, assembly, and performance specifications before shipment.The case details were reviewed.A centrally positioned access was gained utilizing micropuncture with ultrasound for guidance.The right common femoral arteriotomy was clear of calcification.No issues were encountered in advancing or withdrawing the procedural sheaths during the case.Following the tavi, heparin and protamine were administered, and an 18f ce manta was deployed to the measured depth for closure.While inserting the bypass tube through the hemostatic valve of the manta sheath, the surgeon encountered resistance attempting to advance the bypass tube into the sheath hub.The first 18f ce manta device and sheath were removed, and a new 18f ce manta device and sheath (same lot number) were loaded and deployed successfully.A capa was previously opened under teleflex quality system to address this issue.Further investigation related to this event will be initiated if the occurrence rate exceeds the limit as per the capa.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that: "tavi procedure, the membrane of the manta sheath was stiff, and the manta catheter couldn't penetrate it.The doctor had to take new device, and that was ok" anatomical insertion site of device: right femoral artery.Device removed and a new manta kit was used.Therapy delayed due to this but not harm to the patient.".

• Brand Name: MANTA 18F
• Common Device Name: MANTA 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: 21696347
• Report Number: 3010252479-2025-00032
• Device Sequence Number: 15620161
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240422(17)251031(10)MN2401578(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 10/31/2025
• Device Catalogue Number: 2115NE
• Device Lot Number: MN2401578
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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