MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 14F; VASCULAR CLOSURE DEVICE

Catalog Number	2156
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for investigation.No return product evaluation could be completed.Case details were reviewed.A (b)(6) male patient (59kgs., 162.6cm., 22.3kg/m2), presented in the or for an evar proc edure.A centrally positioned access was gained utilizing a micro puncture kit with ultrasound for guidance.The right common femoral arteriotomy was 9.0mm, with mild calcification, wall calcification, and a measured deployment depth of 3cm + 1cm.Before closure, clotting time (act) was 265, and systolic blood pressure was 190/110.The 14f manta was deployed to the measured deployment depth for closure.Two minutes post-deployment, protamine was administered, and hemostasis was achieved in six minutes.One day post-procedure, the physician reported that the patient required surgical repair because the collagen was lodged intraarterially.Therefore, the root cause of the delivery of the implant not being effective in creating hemostasis requiring surgical cutdown is due to user error in deploying the entire manta device intravascular.Numerous causes for intraarterial deployment have been established.However, the exact reason for this intraarterial deployment is potentially due to user error.The manta instructions for use (ifu) posts warning: do not use manta if the patient has post-procedure blood pressure >180 mmhg that cannot be lowered before access site closure.Ifu procedure requirements state activated clotting time (act) should be below 250 seconds before closure, and anticoagulation should be administered at procedure initiation per the hospital's standard of care.The following potential adverse events related to the deployment of vascular closure devices include ischemia of the leg or stenosis of the femoral artery, and other access site complications leading to bleeding, hematoma, pseudoaneurysm, or arterio-venous fistula, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.There appears to be no product quality issue concerning manufacture, documentation, or labeling.The der process will continue to monitor and investigate any similar events.There appears to be no product quality issue concerning manufacture, documentation, or labeling.The der process will continue to monitor and investigate any similar events.
Event or Problem Description
It was reported that "case date (b)(6)2024 - the doctor reported that the collagen had become lodged inside vessel which required surgical repair".Additional information: "micro puncture and ultrasound were utilized to gain central access in the right cfa.Vessel size was 9mm with mild calcification and no reported tortuosity.".
Event or Problem Description
It was reported that "case date (b)(6) 2024 - the doctor reported that the collagen had become lodged inside vessel which required surgical repair".Additional information: "micro puncture and ultrasound were utilized to gain central access in the right cfa.Vessel size was 9mm with mild calcification and no reported tortuosity.".
Additional Manufacturer Narrative
(b)(4).The device lot history record review for lot number 73e2400012 manta 14f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.

• Brand Name: MANTA 14F
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21342080
• Report Number: 3010252479-2025-00007
• Device Sequence Number: 7854682
• Product Code: MGB
• UDI-Device Identifier: 10856279007328
• UDI-Public: (01)10856279007328(11)240501(17)251101(10)73E2400012(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/17/2025

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: 11/01/2025
• Device Catalogue Number: 2156
• Device Lot Number: 73E2400012
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2024
• 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