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

Catalog Number	2115
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Failure to Seal (4070)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a thoracic endovascular aortic repair (tevar) procedure, the manta 18f vascular closure device failed to achieve closure of the right femoral artery.A surgical cutdown was subsequently performed to close the arteriotomy.Good-faith efforts were made to obtain additional information regarding the reported device issue and to assess whether any patient harm, injury, or adverse health consequences occurred; however, no additional information was provided by the user hospital.
Event or Problem Description
It was reported that during a thoracic endovascular aortic repair (tevar) procedure, the manta 18f vascular closure device failed to achieve closure of the right femoral artery.A surgical cutdown was subsequently performed to close the arteriotomy.Good-faith efforts were made to obtain additional information regarding the reported device issue and to assess whether any patient harm, injury, or adverse health consequences occurred; however, no additional information was provided by the user hospital.
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and a potential finding was identified.As no sample was returned for investigation, it could not be determined if the finding was relevant to the reported event.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: 18F MANTA VASCULAR CLOSURE DEVICE
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton PA
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton PA 19341
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25045094
• Report Number: 3010252479-2026-00015
• Device Sequence Number: 21435289
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)250325(17)260925(10)73C2500948(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/06/2026

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: 09/25/2026
• Device Catalogue Number: 2115
• Device Lot Number: 73C2500948
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2025
• 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: Unknown