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	09/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "manta device failed immediately, tissue tract deployment.Additional information: during an evar micropuncture and ultrasound were utilised to gain central access in the common femoral artery.Vessel size was 8+mm with no reproted calcification or tortuosity.Measured depth for the manta was 2+1.10k units of of heparin and 75mg of protamine were administered during the procedure.Hemostasis was not achieved after manta was deployed.Surgical cutdown was performed and the manta was explanted.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The details of the complaint detail were reviewed.No unit was returned for evaluation.As per the additional information received, procedure performed was evar.Access site was right femoral artery.No calcification or tortuosity noted.No lumen kinks observed.The measured depth was 2+1 cm.Manta was deployed at the measured depth.Hemostasis failed with bleeding observed.Manta was explanted with a surgical cutdown.The manta deployed in the tract is indicative of deployment done deviating from the measured depth.Without images or angiogram videos, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor for similar issues.
Event or Problem Description
It was reported that: "manta device failed immediately, tissue tract deployment.Additional information: during an evar micropuncture and ultrasound were utilised to gain central access in the common femoral artery.Vessel size was 8+mm with no reproted calcification or tortuosity.Measured depth for the manta was 2+1.10k units of heparin and 75mg of protamine were administered during the procedure.Hemostasis was not achieved after manta was deployed.Surgical cutdown was performed and the manta was explanted.

• 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: 23242304
• Report Number: 3010252479-2025-00097
• Device Sequence Number: 16001297
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)250325(17)260925(10)73C2500948(21)
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 09/13/2025

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: 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: 09/13/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/06/2025
• 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