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

Catalog Number	2115NE
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	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: " during the tavi procedure when the physician opened the manta device, he saw that the bypass tube with the anchor and collagen inside the tube went outside of the delivery tube.However, the physician tried to connect the manta device to the manta sheath, but without success.The connection between the device and sheath was impossible.Then the physician decided to use second device, and everything finished perfect." additional information: "insertion occurred in the invasive cardiology department.Micro puncture and ultrasound were utilized to gain central access.There was no reported calcification.Anatomical insertion site of the device: femoral artery.The device kinked during the attempt.Issue resolved by using another manta device and was successful.".
Additional Manufacturer Narrative
(b)(4) udi will be added to the follow up report.
Event or Problem Description
It was reported that: " during the tavi procedure when the physician opened the manta device, he saw that the bypass tube with the anchor and collagen inside the tube went outside of the delivery tube.However, the physician tried to connect the manta device to the manta sheath, but without success.The connection between the device and sheath was impossible.Then the physician decided to use second device, and everything finished perfect." additional information: "insertion occurred in the invasive cardiology department.Micro puncture and ultrasound were utilized to gain central access.There was no reported calcification.Anatomical insertion site of the device: femoral artery.The device kinked during the attempt.Issue resolved by using another manta device and was successful.".
Additional Manufacturer Narrative
Qn#(b)(4).One unit of manta and sheath were returned for evaluation.Blood particulates were noted on the unit.The unit was decontaminated and inspected.The delivery tube was observed to have a kink.Displacement of the valve was noted.The device lot history record review for lot number mn2201438 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.Following the tavi, an 18f 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 severe resistance attempting to advance the bypass tube into the sheath hub.Bending and kinking occurred to the manta device when met with resistance.The first 18f ce manta device and sheath were removed, and a new 18f ce manta device and sheath (lot number mn2401574) were loaded and deployed successfully.A capa was previously opened under teleflex quality system to address this issue.Based on the investigation, the root cause has been determined to be manufacturing related.Further investigation related to this event will be initiated if the occurrence rate exceeds the limit as per the capa.Teleflex will continue to monitor and trend on complaints of this nature.

• 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: 21695612
• Report Number: 3010252479-2025-00031
• Device Sequence Number: 15718056
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)220118(17)230718(10)MN2201438(21)
• Combination Product (Y/N): N
• 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): 03/04/2025

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: 07/18/2023
• Device Catalogue Number: 2115NE
• Device Lot Number: MN2201438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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