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

Catalog Number	2115
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi will be provided with the follow up report.
Event or Problem Description
It was reported that: "post tavr procedure, physician met severe resistance while attempting to advance the manta bypass tube through the valve of the manta sheath.Several attempts were made to advance.Manta sheath was removed and a new second manta sheath was placed.Successful deployment with the second manta device." additional information: "access was in the right common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.Measured depth for the manta was 6+1 and the time to hemostasis was immediate post deployment of the second manta.There was no reported patient harm.".
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.The device lot history record review for lot number 73e2400582 manta 18f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.Case details were reviewed.Following the tavr, an 18f manta was deployed to the measured depth for closure.While inserting the bypass tube through the hemostatic valve of the manta sheath, the surgeon encountered severe resistance attempting to advance the bypass tube into the sheath hub.Several attempts were made to advance the bypass tube into the sheath hub but were unsuccessful.The first 18f manta device and sheath were removed, and a second 18f manta device and sheath were loaded onto the guidewire and deployed without issue.A capa was previously opened under teleflex quality system to address this issue.Based on the investigation, the root cause has been determined to be manufacturing related.Further investigation related to this event will be initiated if the occurrence rate exceeds the limit as per the capa.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "post tavr procedure, physician met severe resistance while attempting to advance the manta bypass tube through the valve of the manta sheath.Several attempts were made to advance.Manta sheath was removed and a new second manta sheath was placed.Successful deployment with the second manta device." additional information: "access was in the right common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.Measured depth for the manta was 6+1 and the time to hemostasis was immediate post deployment of the second manta.There was no reported patient harm.".

• 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: 21811882
• Report Number: 3010252479-2025-00039
• Device Sequence Number: 9009438
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240515(17)251115(10)73E2400582(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/19/2025

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: 11/15/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73E2400582
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2024
• 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: 76 YR
• Patient Sex: Male