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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "continued bleeding from the site post deployment.Possible vessel dissection/damage revealed via angiogram.Surgical cutdown/repair was performed to the site." additional information: " micro puncture and ultrasound were utilized to gain central access in the left common femoral artery.Vessel size was mm with moderate calcification and some tortuosity noted.Measured depth for the manta was 7+1=8.When attempting to advance the sheaths during the procedure they had to be exchanged multiple times due to difficulty traversing the vessel.Systolic blood pressure was 149mmhg.Act greater than 250 at time of deployment.12 thousand units of heparin was administered during the procedure.Time to hemostasis was approximately 20 minutes.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "continued bleeding from the site post deployment.Possible vessel dissection/damage revealed via angiogram.Surgical cutdown/repair was performed to the site." additional information: " micro puncture and ultrasound were utilized to gain central access in the left common femoral artery.Vessel size was mm with moderate calcification and some tortuosity noted.Measured depth for the manta was 7+1=8.When attempting to advance the sheaths during the procedure they had to be exchanged multiple times due to difficulty traversing the vessel.Systolic blood pressure was 149mmhg.Act greater than 250 at time of deployment.12 thousand units of heparin was administered during the procedure.Time to hemostasis was approximately 20 minutes.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).The customer report of "possible vessel dissection/damage" post manta deployment was confirmed by visual inspection of the customer supplied angiograms.However, full 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.Additional information was received from the sales representative in the case that there were issues inserting and removing the procedure sheaths and that the sheaths were switched out multiple times during the procedure due to difficulty traversing the vessel.The product ifu states "the safety and effectiveness of the manta device has not been established in the following patient populations: patients who are suspected of having intra-procedural complications at the femoral access site before sheath removal including: bleeding or swelling around the large bore sheath that may indicate hematoma formation and/or pseudoaneurysm formation, and/or peri-procedural angiographic evidence of thrombus formation or significant injury in the aorta or iliac vessels associated with procedural large bore sheath placement and/or sub-optimal anticoagulation".However, without the device to evaluate, the probable cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 23093537
• Report Number: 3010252479-2025-00092
• Device Sequence Number: 9809146
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240508(17)251108(10)73E2400257(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): 08/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73E2400257
• 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: 08/25/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2024
• 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 Age: 81 YR
• Patient Sex: Unknown
• Patient Weight: 91 KG