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	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "device footplate did not release when blue level was flipped.The box was brand new and we used 2 and they both did the same thing.We had to use a different lot number to close the groin.There was severe resistance noted when attempting to advance the sheath into the bypass tube.There was no reported patient harm or consequence.They were reported as fine post the procedure." associated complaint 3010252479-2025-00069.
Additional Manufacturer Narrative
Qn #: (b)(4).The reported issue of severe resistance experienced during bypass tube advancement was able to be confirmed through investigation of the returned sample.The customer returned two used manta delivery systems and three unused manta delivery systems from the same lot for evaluation.Visual analysis revealed the button valve was dislodged.The button valve was torn and the sheath was advanced over the device and correctly attached.The anchor was also misplaced in the inner lumen of the device.It is likely that the customer experienced resistance during advancement of the bypass tube and continued to apply force, leading to damage to the device.The ifu states "if significant resistance is felt inserting the bypass tube into the manta sheath, remove the entire system and open a new device." a device history record review was performed, and no relevant findings that contributed to the event were identified.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 customer report and the sample rece ived, a combination of a supplier manufacturing defect and unintentional user error likely caused or contributed to this event.
Event or Problem Description
It was reported that: "device footplate did not release when blue level was flipped.The box was brand new and we used 2 and they both did the same thing.We had to use a different lot number to close the groin.There was severe resistance noted when attempting to advance the sheath into the bypass tube.There was no reported patient harm or consequence.They were reported as fine post the procedure." associated complaints 3010252479-2025-00070 and 3010252479-2025-00069.

• 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: 22217494
• Report Number: 3010252479-2025-00070
• Device Sequence Number: 8659444
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240605(17)251205(10)73F2400237(21)
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 06/03/2025

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: 12/05/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73F2400237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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