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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Retroperitoneal Hemorrhage (4483)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "u/s used for access with micro-introducer kit.Noted high single stick, but in the center of fa, which measures 8.7mm.Md was notified by me that access was not optimal, but continued to move forward.Tavr performed through right fa with a 18fr sheath.Medtronic 29mm valve deployed with no complications.18fr manta device used per ifu and appeared to have optimal result with no oozing or extravasation.Followed up with patient after 15 min and groin was soft.Pt moved to recovery with no issues.Pt had rp bleed late in the day in recovery.Pt was brought back to cath lab for covered stent.Pt is fine".
Additional Manufacturer Narrative
(b)(4) the details of the complaint were reviewed.No unit was returned for evaluation.A device history record review was performed, and no relevant findings were identified.Angiograms were provided and reviewed with cma.The access site appears to be close to the femoral head that likely represents the high stick access as reported in the complaint.No extravasation noted but a minor blush was observed.Flow could be observed downstream.Video of stent deployment performed was confirmed.The ifu along with this product states: do not use if the puncture site is proximal to the inguinal ligament or above the most inferior border of the epigastric artery (iea), as this may result in retroperitoneal bleeding.The following potential adverse events related to the deployment of vascular closure devices have been identified:- retroperitoneal bleeding, and its consequences, as a result of failed closure in the setting of an access above the inguinal ligament or the most inferior border of the epigastric artery (iea)- other access site complications leading to bleeding, hematoma, pseudoaneurysm, or arterio-venous fistula, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.Additional information noted that 2 covered stents were placed with success.2 units of blood transfusion were given.The patient condition is fine.Based on the information, the most likely root cause of the issue is user error due to high stick access.
Event or Problem Description
It was reported that "u/s used for access with micro-introducer kit.Noted high single stick, but in the center of fa, which measures 8.7mm.Md was notified by me that access was not optimal, but continued to move forward.Tavr performed through right fa with a 18fr sheath.Medtronic 29mm valve deployed with no complications.18fr manta device used per ifu and appeared to have optimal result with no oozing or extravasation.Followed up with patient after 15 min and groin was soft.Pt moved to recovery with no issues.Pt had rp bleed late in the day in recovery.Pt was brought back to cath lab for covered stent.Pt is fine".

• 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: 23448121
• Report Number: 3010252479-2025-00107
• Device Sequence Number: 8073638
• 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: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: 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: 10/03/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/27/2025
• 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
• Patient Sex: Unknown