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	Hematoma (1884)
Date of Event	09/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "micro puncture and ultrasound were utilised to gain central access in the right common femoral artery.Vessel size was 8mm and measured depth for the manta was 2+1 act was 320 at time of deployment and then 10g protamine was given.A hematoma started forming immediately under the skin post manta deployment.A femstop was applied to treat hematoma.2.5 hours later the femstop was removed in the recovery room and the patients bp dropped.The patient coded and cpr was performed.Patient had to come back for re-access on the opposite side and balloon tamponade for 10 mins.They were reported as fine post the incident.No blood transfusion was needed.".
Event or Problem Description
It was reported that: "micro puncture and ultraound were utiilised to gain central access in the right common feoral artery.Vessel size was 8mm and measured depth for the manta was 2+1 act was 320 at time of deployment and then 10g protamine was given.A hematoma started forming immediately under the skin post manta deployment.A femstop was applied to treat hematoma.2.5 hours later the femstop was removed in the recovery room and the patients bp dropped.The patient coded and cpr was performed.Patient had to come back for re-access on the opposite side and balloon tamponade for 10 mins.They were reported as fine post the incident.No blood transfusion was needed.".
Additional Manufacturer Narrative
(b)(4).The details of the complaint were reviewed.No unit was returned for evaluation.As per the additional information received, access vessel was right common femoral artery without any significant calcification or tortuosity.The deployment depth was 2+1 cm.No issues observed with the procedural sheaths.Hemostasis was not achieved immediately after manta deployment.Manual pressure and fem stop were employed after manta deployment.The fem stop was applied for 2.5 hours.No abnormal patient movement noted.Post procedure, femstop was removed.Hematoma was present.Patient coded for blood pressure drop and was brought back to emergency.Cpr was done without any blood transfusion.No information was provided on hemodynamics on prior, during and post bleeding.No rp bleed observed.Balloon intervention was employed from the left side access.Ballooning was done for 10 mins.Images and videos of the ballooning were shared.Manta lock position was confirmed.Flow downstream was noted.No bleeding or extravasation observed.No images prior to balloon intervention were provided.A device history record review was performed, and no relevant findings were identified.It is unknown what could have caused the hemostasis issue or why hematoma was formed.Based on the information, the most likely root cause of the issue is undeterminable.Teleflex will continue to monitor for similar issues.

• 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: 23243079
• Report Number: 3010252479-2025-00103
• Device Sequence Number: 10245534
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)250408(17)261008(10)73D2500306(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): 09/19/2025

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 Catalogue Number: 2156
• Device Lot Number: 73D2500306
• 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: 09/19/2025
• 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: 04/08/2025
• 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: Male