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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during a tavr procedure, following the deployment of the 18f manta bleeding was observed.Manual pressure was applied for 20 minutes but surgical intervention was needed.The patient was reported as fine post 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, there was no movement of the patient or access site during recovery.A 12mm balloon was used to facilitate hemostasis.Manual pressure was held for 20 minutes.An amplatz wire was used to deploy the manta device.It is unknown if the manta was positioned correctly in the vessel.The vessel size was 9mm, a micropuncture kit was used, no ultrasound was used, and only one attempt was needed.The access location of the common femoral artery was central.No calcification or tortuosity was noted.There were no issues with procedure sheaths, and the procedure was performed per ifu.The manta was deployed at the measured depth of 3.5+1.No resistance was noted when advancing the bypass tube into the manta sheath.The manta device was explanted during the surgical cut down.Patient outcome is fine and there was no patient harm.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the ava ilable information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during a tavr procedure, following the deployment of the 18f manta bleeding was observed.Manual pressure was applied for 20 minutes but surgical intervention was needed.The patient was reported as fine post the procedure.".

• 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: 23231357
• Report Number: 3010252479-2025-00096
• Device Sequence Number: 10033787
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240611(17)251211(10)73F2400402(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73F2400402
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2024
• 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 Sex: Male