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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "dr deployed the 18f manta per ifu instructions.When the post angiogram was taken , we notice the femoral artery was occluded.He proceeded to balloon the site which resolved the issue." additional information: "during the tavr procedure micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.Measured depth for the manta was 3+1cm.Both heparin and protamine were administered intravenously during the procedure.No cut down was performed, the occlusion was resolved with a balloon and the patient was reported to be fine post the procedure.".
Event or Problem Description
It was reported that: "dr deployed the 18f manta per ifu instructions.When the post angiogram was taken , we notice the femoral artery was occluded.He proceeded to balloon the site which resolved the issue." additional information: "during the tavr procedure micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.Measured depth for the manta was 3+1cm.Both heparin and protamine were administered intravenously during the procedure.No cut down was performed, the occlusion was resolved with a balloon and the patient was reported to be fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).The customer report of manta occlusion was able to be confirmed through the review of the customer report and supplied additional information.Complaint verification testing could not be performed as no sample was returned for analysis.The details of the complaint were reviewed.The anchor was deployed correctly, and it was reported that the collagen deployed in the vessel leading to occlusion.A device history record review was performed, and no findings that could have contributed to this event were identified.Based on the information available, the probable cause is most likely an unintentional use error.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 22211223
• Report Number: 3010252479-2025-00065
• Device Sequence Number: 18182150
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240116(17)250716(10)73A2400442(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): 05/21/2025

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 Expiration Date: 07/16/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73A2400442
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2024
• 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.
• Patient Sex: Unknown