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

Catalog Number	2115
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "device fell apart on deployment.Physician was able to hold pressure and use another device and outcome was successful.Additional information states that there was moderate resistance felt when attempting to advance the bypass tube.".
Event or Problem Description
It was reported that: "device fell apart on deployment.Physician was able to hold pressure and use another device and outcome was successful.Additional information states that there was moderate resistance felt when attempting to advance the bypass tube.".
Additional Manufacturer Narrative
(b)(4).The customer report of a manta sheath falling apart was able to be confirmed through investigation of the returned sample.Visual analysis revealed that the sheath hub/tube was disconnected from the sheath housing.Stress marks and deformation were noted on the sheath hub clips.This damage is indicative of friction, tension, or undue force applied to the sheath hub.The components were reassembled, and the connection was secure.The returned components passed all relevant dimensional requirements.A device history record review was performed, and no relevant findings were identified.Additional information provided by the customer reported that "moderate" resistance was encountered when introducing the bypass tube.This issue cannot be functionally replicated as the components were disengaged when the unit was returned.The button valve was observed to be pierced correctly.A capa was previously initiated under teleflex's quality systems for bypass tube resistance that was attributed to a supplier manufacturing deficiency and the corrective actions were implemented.Further investigation related to this event will be initiated if the occurrence rate exceeds the limit as per the capa.Furthermore, 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." based on the customer report and the sample received, a combination of manufacturing deficiency and unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for events of this nature.

• 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: 22024571
• Report Number: 3010252479-2025-00055
• Device Sequence Number: 17947115
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240515(17)251115(10)73E2400582(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/21/2025

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: 11/15/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73E2400582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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