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

Catalog Number	2156
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "pulsatile bleeding post deployment".Additional information: "during a peripheral ventricular assisted device pvad coronary intervention.Micro puncture and ultrasound were utilized to gain access in the right access at mid femoral head.Vessel size was 8mm with no reported calcification or tortuosity.Measured depth for the manta was 3+1cm.7000 heparin was administered during the procedure.Protamine was not given.Systolic bp was 160 and act 297 manta was deployed successfully but pulsatile flow was present.Deployment was confirmed under fluoro and proximal dissection was noted after imaging.Patient was reported as fine post procedure.".
Additional Manufacturer Narrative
(b)(4).The device was not returned for investigation.No return product evaluation could be completed.Case details were reviewed.The patient presented in the or for a protected pci with pvad.A centrally positioned access was gained utilizing a micro puncture kit with ultrasound for guidance.The right femoral arteriotomy was 8.0mm, clear of calcification and tortuosity, with a measured deployment depth of 3.0cm + 1cm.No issues were encountered advancing or withdrawing the 14f pvad sheath during the case.Following the protected pci, the activated clotting time measured was 297, heparin was administered and a 14f manta device was deployed to the measured depth.The physician pulled the sheath back to the deployment depth during the deployment procedure before the manta handle was connected to the sheath hub.The device was removed from the guidewire and the sheath was readvanced until it was hubbed at the skin.Deployment was confirmed under fluoroscopy although a dissection was noted, and pulsatile bleeding was present.Manual pressure was applied for ten minutes and a covered stent was placed, restoring flow.Dissections are a common large-bore procedure complication.The proctor noted this physician was a new user on his second deployment and noted while readvancing the sheath, it is likely the cause of the dissection seen proximal to the access site, causing the bleed.There is believed to be no device failure, the device was successfully implanted.The root cause of the pulsatile bleeding requiring a covered stent is likely user error due to the formation of a dissection proximal to the access.The severity of harm is ranked as a 4 due to endovascular intervention requiring stenting used as a treatment for the dissection.The patient outcome post-procedure was fine.The manta instructions for use (ifu) precautions if bleeding from the femoral access site persists after using the manta device, assess the situation.Based on the amount of bleeding, use manual or mechanical compression, apply balloon pressure, place a covered stent, and/or surgical repair to obtain hemostasis.The following potential adverse events related to the deployment of vascular closure devices include local trauma to the femoral or iliac artery wall, such as dissection and other access site complications leading to bleeding, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.Potential adverse events associated with any large bore intervention, including the use of the manta vascular closure device, include but are not limited to late arterial bleeding and vessel laceration or trauma.Ifu procedure requirements state activated clotting time (act) should be below 250 seconds before closure.Conclusion code user error: there appears to be no product quality issue concerning manufacturing, documentation, or labeling.The der process will continue to monitor and investigate any similar events.
Additional Manufacturer Narrative
Qn#(b)(4).Udi related data quality updates only section d.4.-unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported that: "pulsatile bleeding post deployment".Additional information: "during a peripheral ventricular assisted device pvad coronary intervention.Micro puncture and ultrasound were utilized to gain access in the right access at mid femoral head.Vessel size was 8mm with no reported calcification or tortuosity.Measured depth for the manta was 3+1cm.7000 heparin was administered during the procedure.Protamine was not given.Systolic bp was 160 and act 297 manta was deployed successfully but pulsatile flow was present.Deployment was confirmed under fluoro and proximal dissection was noted after imaging.Patient was reported as fine post procedure.".

• 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: 21066697
• Report Number: 3010252479-2025-00001
• Device Sequence Number: 8484713
• 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: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 12/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/07/2025
• 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
• Patient Sex: Unknown