MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 14FR; 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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " the main issue was the bypass tube.It was very difficult to advance into the valve of the sheath, it would not go at all.The physician left the existing sheath in the body and pulled a new closure unit and deployed that into the existing sheath with much better ease.It was not smooth but easier than the first closure unit.There was no harm to the patient.".
Additional Manufacturer Narrative
(b)(4).Functional testing was attempted by inserting the bypass tube into the button valve.Severe resistance was confirmed.A device history record review was performed and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user "if significant resistance is felt inserting the bypass tube into the manta sheath, remove the entire system and open a new device" and "if the manta delivery system becomes kinked during insertion into the sheath, remove the entire system and open a new device".Complaint of bypass tube resistance was able to be confirmed through sample investigation.Visual inspection revealed a kink on the closure device indicative of bypass tube resistance.There was no damage or tear on the button valve.Functional testing was performed in which the closure device was re-attempted to be inserted into the sheath and severe resistance was noted.A device history record review was performed and no relevant findings were identified.The ifu states "if the manta delivery system becomes kinked during insertion into the sheath, remove the entire system and open a new device".The current complaint rate for bypass tube resistance is (b)(4) (january 2026) which is within occurrence limits, therefore no escalation is required.Based on the information received, the most likely root cause for the bypass tube resistance is supplier related.

• Brand Name: MANTA 14FR
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton PA
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton PA 19341
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24400225
• Report Number: 3010252479-2026-00006
• Device Sequence Number: 8223633
• Product Code: MGB
• UDI-Device Identifier: 10841156111359
• UDI-Public: (01)10841156111359(11)250923(17)270323(10)73J2500865(21)
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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 Catalogue Number: 2156
• Device Lot Number: 73J2500865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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.
• Patient Sex: Unknown