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

Catalog Number	2115
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "continued bleeding from access site post manta device deployment.Angiogram revealed extravasation from the access site.2 overlapping covered stents we placed across the access site and manual pressure was held for 30 minutes post procedure".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "continued bleeding from access site post manta device deployment.Angiogram revealed extravasation from the access site.2 overlapping covered stents we placed across the access site and manual pressure was held for 30 minutes post procedure".
Additional Manufacturer Narrative
(b)(4).The customer report of continued bleeding from the access site post-manta device deployment was confirmed through visual review of customer-provided photos.The first image, an angiogram obtained after device deployment, shows post-deployment bleeding at the access site.The second image, an angiogram after stent deployment, shows the radiopaque lock positioned away from the vessel wall.Additional information indicated that the manta device was deployed at the measured depth.No resistance was reported during advancement of the blue lock advancement tube; however, it is unknown whether the gray indicator band at the proximal tip of the delivery tube was visible following lock advancement.Clinical affairs reviewed the images and indicated that the event may be due to either incomplete collagen compaction or tract deployment.As the device was reportedly deployed at the measured depth, no anatomical changes affecting arteriotomy depth were noted, and visibility of the gray indicator band could not be confirmed, the event was determined to be most likely related to incomplete collagen compaction.The instructions for use (ifu) state: "with tension removed, a visible gray indicator band at the proximal tip of the delivery tube will confirm the radiopaque lock is fully advanced and collagen is compacted.".A review of the device history record revealed no relevant findings.Based on review of the customer report and images, unintended user error likely caused or contributed to the event.

• 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: 23876975
• Report Number: 3010252479-2025-00118
• Device Sequence Number: 14629243
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)250806(17)270206(10)73H2500223(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): 12/01/2025

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: 2115
• Device Lot Number: 73H2500223
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• 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
• Patient Sex: Unknown