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

Catalog Number	2156
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "14 fr manta device failure during peripheral ventricular assist device (pvad) removal case.Pvad sheath was removed and exchanged for manta sheath.Severe valve resistance was experienced during introduction of manta device requiring more force and eventually the tip was damaged so another device was opened.During introduction into the same sheath, the manta sheath hub dismantled and broke apart.A third device was opened and manta sheath exchanged.Same valve resistance was experienced but was able to manage and get the manta device through and clicked together.Deployment went well but some extravasation was seen on angiogram.Went back up on manta tension for re-extension and the suture cut into the advancement tube and malfunctioned.An alternative suture mediated closure device was deployed to cinch up the remaining leak with good results." associated complaints 3010252479-2025-00100, 3010252479-2025-00099.
Event or Problem Description
It was reported that "14 fr manta device failure during peripheral ventricular assist device (pvad) removal case.Pvad sheath was removed and exchanged for manta sheath.Severe valve resistance was experienced during introduction of manta device requiring more force and eventually the tip was damaged so another device was opened.During introduction into the same sheath, the manta sheath hub dismantled and broke apart.A third device was opened and manta sheath exchanged.Same valve resistance was experienced but was able to manage and get the manta device through and clicked together.Deployment went well but some extravasation was seen on angiogram.Went back up on manta tension for re-extension and the suture cut into the advancement tube and malfunctioned.An alternative suture mediated closure device was deployed to cinch up the remaining leak with good results." associated complaint 3010252479-2025-00099.
Additional Manufacturer Narrative
(b)(4).The customer complaint of bypass tube resistance and subsequentially the sheath separating from the housing was confirmed through the investigation of the returned sample.The customer returned two manta closure devices for investigation and one detached sheath.Visual analysis revealed damage to the sheath in the form of a tear near the proximal hub where it seems to have kinked.The tabs on the sheath hub had pieces of orange resin hanging off indicative of the damage from detaching from the sheath housing.On the first device, the button valve was not sitting within the sheath housing and seemed to have not torn correctly.The button valve was also very difficult to remove from the sheath.Dimensional testing was done on the button valve and the outer diameter measured 14.7mm which was below the lower specification limit of 15.7mm.A device history record review was performed and there were no relevant findings.Based on the customer report and the sample received, the root cause is supplier related.Further investigation has been initiated under teleflex quality systems to evaluate this issue.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23255548
• Report Number: 3010252479-2025-00100
• Device Sequence Number: 10414224
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)250311(17)260911(10)73C2500437(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/16/2025

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: 09/11/2026
• Device Catalogue Number: 2156
• Device Lot Number: 73C2500437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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