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

Catalog Number	2115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "continued bleeding from site.Angiogram revealed possible dissection near the access (arteriotomy).Covered stent placed.No other harm to the patient.".
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of "continued bleed from site" was not able to be confirmed.Visual analysis of the provided angiograms revealed a stent visible within the central femoral artery.The manta radiopaque lock is visible and appears to be correctly positioned.No angiograms showing the reported extravasation prior to stenting were provided.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 requested, and a response was received.The dissection was noted near the arteriotomy and was likely caused by the procedural sheath.The flow was not obstructed due to the dissection.Time to hemostasis was approximately 15 minutes.There was no harm or health consequences to the patient.Without the device to evaluate, 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.Angiogram revealed possible dissection near the access (arteriotomy).Covered stent placed.No other harm to the patient.".

• Brand Name: MANTA 18FR
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton PA
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton PA 19341
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24696801
• Report Number: 3010252479-2026-00012
• Device Sequence Number: 10046589
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)251013(17)270413(10)73K2500563(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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 73K2500563
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2025
• 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 Age: 73 YR
• Patient Sex: Male