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

Catalog Number	2156
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "post tavr, suture-mediated closure system x 3 utilized for closure and then manta 14fr for bailout procedure.First 2 manta had valve resistance issues, 3rd 14fr manta was deployed and worked properly to close the groin." associated complaints 3010252479-2025-00079.
Event or Problem Description
It was reported that: "post tavr, suture-mediated closure system x 3 utilized for closure and then manta 14fr for bailout procedure.First 2 manta had valve resistance issues, 3rd 14fr manta was deployed and worked properly to close the groin." associated complaints 3010252479-2025-00078 and 3010252479-2025-00079.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of valve resistance experienced during advancement was able to be confirmed through review of the customer report and supplied additional information; however, complaint verification testing could not be performed as no sample was returned for analysis.The first two mantas had valve connection issues.The ifu states that, if significant resistance is felt inserting the bypass tube into the manta sheath, remove the entire system and open a new device.A capa was previously initiated for bypass tube resistance that was attributed to a supplier manufacturing deficiency.Corrections were implemented.The complaint rate for bypass tube resistance is within occurrence limits as defined in capa, and further investigation related to this event will be initiated if the occurrence rate exceeds the limit.Based on the information received, the most likely root cause is supplier related.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 22724323
• Report Number: 3010252479-2025-00078
• Device Sequence Number: 18228890
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)241022(17)260422(10)73K2400781(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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 04/22/2026
• Device Catalogue Number: 2156
• Device Lot Number: 73K2400781
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2024
• 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