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

Catalog Number	2115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "did a aaa case with dr.(b)(4)., during closure two manta's were deployed.The 14 fr manta was deployed on the left side with no incident.During the deployment of the 18fr manta on the right-side dr.(b)(4).Pulled to tension and the suture broke.Dr.(b)(6).Preformed a surgical cutdown to close the groin he was able repair artery and pt had good distal pulses after repair.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The details of the complaint were reviewed.Two audible clicks were heard during deployment.The tension gauge showed red as the device was pulled to tension and when the suture broke.The instructions-for-use (ifu) provided with this device states, "note: do not pull past green.Excessive force may cause vessel damage.".Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "did a aaa case with dr (b)(6), during closure two manta's were deployed.The 14 fr manta was deployed on the left side with no incident.During the deployment of the 18fr manta on the right-side dr (b)(6) pulled to tension and the suture broke.Dr (b)(6) preformed a surgical cutdown to close the groin he was able repair artery and pt had good distal pulses after repair.".

• 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: 23886821
• Report Number: 3010252479-2025-00121
• Device Sequence Number: 4671945
• Product Code: MGB
• UDI-Device Identifier: 10841156111335
• UDI-Public: (01)10841156111335(11)250325(17)260925(10)73C2500948(21)
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/02/2025

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: 09/25/2026
• Device Catalogue Number: 2115
• Device Lot Number: 73C2500948
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2025
• 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