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

Catalog Number	2115
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the complaint of bypass tube resistance was confirmed through sample investigation.Visual analysis revealed the manta lever was actuated and the anchor was deployed.The sheath was detached from the manta device and there was no damage to the bypass tube.The button valve was not damaged or incorrectly torn.Based on the complaint description the resistance was experienced before the manta lever was actuated and deployed.The description states "physician removed the manta device from over the wire undeployed and removed the manta sheath." dimensional testing of the button valve passed.Functional testing was attempted by inserting the bypass tube into the manta sheath.Severe resistance was experienced.A device history record review was performed, and no relevant findings were identified.A device history record review was performed, and no relevant findings were identified.Additional information was received.There was no movement of the patient or access site during recovery.An wire was used.The right common femoral artery was accessed centrally.Vessel size was 6.9mm.A micropuncture kit with ultrasound was used and multiple attempts were needed to gain access.Mild calcification was noted medial in the vessel.No tortuosity was noted.The manta depth measured was 3+1.The manta was positioned correctly in the vessel.Time to hemostasis was immediate.A 14fr edwards e-sheath was used.There were no issues advancing or withdrawing procedure sheaths.Heparin ivp and protamine ivp were given.No cut down was needed and patient outcome was stable.Based on the information received, the most likely root cause for the bypass tube resistance is supplier related.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " physician met severe resistance attempting to advance manta device through manta sheath post tavr procedure.Physician removed the manta device from over the wire undeployed and removed the manta sheath.A second manta sheath was advanced and successfully closed with second manta device.".

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24530789
• Report Number: 3010252479-2026-00008
• Device Sequence Number: 8894788
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)251010(17)270410(10)73K2500562(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 02/11/2026

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 Catalogue Number: 2115
• Device Lot Number: 73K2500562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2025
• 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
• Patient Sex: Unknown