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

Catalog Number	2156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "continued bleeding from site post procedure.Angiogram revealed no extravasation.8.0x40mm peripheral balloon inflated across access site and proximal(illiac), with no effect on the bleeding.Physician believes that manta likely deployed correctly, and that the bleeding was possibly from incidental venous damage instead." additional information: "operating interventional cardiologist stated that: the artery was intact, and the manta device was positioned correctly in the vessel.The ic reported that the bleeding was venous which could have occurred during initial access.The manta device was never explanted and the surgical cutdown was to repair the femoral vein.The ic reported that the manta deployment was not contributory to damaged vessel that resulted in the surgical cut down.After the surgical procedure, it was reported that the patient is doing well, and no health consequences occurred from this event.".
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.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.
Event or Problem Description
It was reported that: "continued bleeding from site post procedure.Angiogram revealed no extravasation.8.0 x 40mm peripheral balloon inflated across access site and proximal(illiac), with no effect on the bleeding.Physician believes that manta likely deployed correctly, and that the bleeding was possibly from incidental venous damage instead." additional information: "operating interventional cardiologist stated that: the artery was intact, and the manta device was positioned correctly in the vessel.The ic reported that the bleeding was venous which could have occurred during initial access.The manta device was never explanted and the surgical cutdown was to repair the femoral vein.The ic reported that the manta deployment was not contributory to damaged vessel that resulted in the surgical cut down.After the surgical procedure, it was reported that the patient is doing well, and no health consequences occurred from this event.".

• 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: 23714178
• Report Number: 3010252479-2025-00117
• Device Sequence Number: 8910392
• Product Code: MGB
• UDI-Device Identifier: 10841156111359
• UDI-Public: (01)10841156111359(11)240925(17)260325(10)73J2400926(21)
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/25/2025

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: 03/25/2026
• Device Catalogue Number: 2156
• Device Lot Number: 73J2400926
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2024
• 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