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	Obstruction/Occlusion (2422)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The details of the complaint were reviewed.No unit was returned to teleflex for evaluation.A video was shared that confirmed the presence of radiopaque lock and flow downstream post the access site.No other view was provided to confirm the occlusion or anchor displacement.The additional information noted that the procedure was a tavr.Edwards e sheath 14f was used.Bmi is unknown.Access site was right cfa with 7.5 mm with no calcification on tortuosity.Manta depth was measure at 2.5+1 cm and deployed at the right depth.No issues observed with the procedural sheaths.Customer could not confirm if the anchor was positioned correctly in the vessel.Collagen was not deployed within the vessel.No dissection noted.The issue resolved with ballooning with a 7x 40 balloon.The patient condition is fine.A device history record review was performed, and no relevant findings were identified.Based on the information, it is unknown what could have caused the flow obstruction post deployment.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during a tavr procedure, micropuncture and ultrasound were utilized to gain lower access in the right common f emoral artery.Vessel size was 7.5mm with no reported calcification or tortuosity.Measured depth for the manta was 2.5cm +1.There was no blood flow post deployment.Ballooned femoral artery with 7 x 40 balloon with flow restored.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during a tavr procedure, micropuncture and ultrasound were utilized to gain lower access in the right common femoral artery.Vessel size was 7.5mm with no reported calcification or tortuosity.Measured depth for the manta was 2.5cm +1.There was no blood flow post deployment.Ballooned femoral artery with 7 x 40 balloon with flow restored.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: 23475921
• Report Number: 3010252479-2025-00108
• Device Sequence Number: 10431481
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)240605(17)251205(10)73F2400237(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 12/05/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73F2400237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2024
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 75 KG