MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 14F; VASCULAR CLOSURE DEVICE

Catalog Number	2156
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when manta was deployed, we noticed a large amount of bleeding.The dr held pressure for 10 minutes and checked for pulses.There were pulses and after 10 minutes there was no bleeding.However, the dr decided to use ultrasound to check the site and saw that the manta device was fully inside of the vessel.So then decided to cutdown and remove manta and repair the artery.The patient was reported as fine post the procedure." additional information: during the procedure, micro puncture and ultrasound were utilized to gain lower access in the left common femoral artery.There was mild anterior calcification reported in the vessel.Measured depth for the manta was 2.5+1.40mg of protamine was administered during the procedure.
Event or Problem Description
It was reported that "when manta was deployed, we noticed a large amount of bleeding.The dr held pressure for 10 minutes and checked for pulses.There were pulses and after 10 minutes there was no bleeding.However, the dr decided to use ultrasound to check the site and saw that the manta device was fully inside of the vessel.So then decided to cutdown and remove manta and repair the artery.The patient was reported as fine post the procedure." additional information: during the procedure, micro puncture and ultrasound were utilized to gain lower access in the left common femoral artery.There was mild anterior calcification reported in the vessel.Measured depth for the manta was 2.5+1.40mg of protamine was administered during the procedure.
Additional Manufacturer Narrative
(b)(4) 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.As per the additional information received, the left common femoral artery was accessed using a micropuncture kit and ultrasound.Only one attempt was needed.The access location of the cfa was low.Mild calcification was noticed anterior in the vessel.No tortuosity was noted.The manta measurement depth was 2.5+1 cm.There were no issues with the procedure sheaths.An amplatz guidewire was used and there was no wire exchange prior to manta deployment.The procedure was performed per the ifu.40 protamine ivp was given.No resistance was experienced when advancing the bypass tube into the manta sheath.The patient outcome was fine and there was no patient harm.It was reported that after extended hemostasis was resolved using manual pressure, the physician used ultrasound to check the site and saw the manta device fully inside the vessel.It's possible that when applying manual pressure, the collagen could have been displaced and moved deeper into the vessel causing complete occlusion.Per customer information, surgical cutdown was performed, the manta was removed, and the artery was repaired.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: MANTA 14F
• 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: 23220325
• Report Number: 3010252479-2025-00095
• Device Sequence Number: 9840508
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)240312(17)250912(10)73C2400437(21)
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/09/2025

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: 09/12/2025
• Device Catalogue Number: 2156
• Device Lot Number: 73C2400437
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male