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

Catalog Number	2115
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "doctor deployed manta in a vessel with mild posterior calcium that was 7mm in size.The foot plate caught on the calcium and deployed the collagen inside the femoral artery".Additional information received states that a surgical cutdown was performed.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The customer complaint of manta occlusion could not be confirmed through review of the customer report and additional information.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 indicated that the procedure being performed was an endovascular aneurysm repair (evar).The procedure sheath was a medtronic 16.The right common femoral artery was accessed centrally.A micropuncture kit was used to gain access with ultrasound, and only one attempt was needed.Mild calcification was noted as being medial located in the vessel.The manta was deployed at the measured depth of 2+1 cm.There were some difficulties with advancing the procedure sheaths.A surgical cutdown was performed and the manta device was explanted.The patient outcome was fine with no harm or health consequences.No problems were reported with the tension gauge or the tamper tube.The manta lumen was not kinked.No pulsatile bleeding was noted post deployment.A j wire was used to deploy the manta device.The customer reported that the physician deployed the manta in a vessel with mild posterior calcium that was 7mm in size.The footplate got caught on the calcium and deployed the collagen inside the femoral artery.Based on the customer report and information available, the probable cause is unintentional use error.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "doctor deployed manta in a vessel with mild posterior calcium that was 7mm in size.The foot plate caught on the calcium and deployed the collagen inside the femoral artery".Additional information received states that a surgical cutdown was performed.No patient harm or injury.The patient status is reported as "fine".

• 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 27560
• MDR Report Key: 23708444
• Report Number: 3010252479-2025-00113
• Device Sequence Number: 10641447
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)250218(17)260818(10)73B2500669(21)
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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): 11/07/2025

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: 08/18/2026
• Device Catalogue Number: 2115
• Device Lot Number: 73B2500669
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2025
• 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: N/A.; N/A.
• Patient Sex: Unknown