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

Catalog Number	2115
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 8mm with no reported calcification or tortuosity.Measured depth for the manta was 4.5+1.Systolic blood pressure was 96/50 and act was 264.Both heparin and protamine were administered during the procedure.Following the deployment of the 18f manta angiography showed evidence of a right common femoral artery occlusion was observed.A covered stent was used to achieve hemostasis.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4) complaint verification testing of an occlusion post deployment could not be performed as no sample was returned for analysis and no angiograms were provided.A device history record review was performed, and no relevant findings were identified.Additional information was received by the customer that a covered stent was placed after the occlusion was observed.Without the device to evaluate, the complaint could not be confirmed, and 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 "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 8mm with no reported calcification or tortuosity.Measured depth for the manta was 4.5+1.Systolic blood pressure was 96/50 and act was 264.Both heparin and protamine were administered during the procedure.Following the deployment of the 18f manta angiography showed evidence of a right common femoral artery occlusion was observed.A covered stent was used to achieve hemostasis.The patient was reported as fine post the procedure.".

• 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: 23220051
• Report Number: 3010252479-2025-00094
• Device Sequence Number: 18581307
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240611(17)251211(10)73F2400402(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/09/2025

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 Expiration Date: 12/11/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73F2400402
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2024
• 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 Sex: Male