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	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "post peripheral ventricular assist device (pvad) removal, physician met severe resistance advancing the bypass tube through the valve of the manta sheath.The manta device would not advance at all into the manta sheath.Physician removed the first manta sheath and opened a second manta.The access site was successfully closed with the second manta device.".
Event or Problem Description
It was reported that: "post peripheral ventricular assist device (pvad) removal, physician met severe resistance advancing the bypass tube through the valve of the manta sheath.The manta device would not advance at all into the manta sheath.Physician removed the first manta sheath and opened a second manta.The access site was successfully closed with the second manta device.".
Additional Manufacturer Narrative
Qn#(b)(4).The customer complaint of bypass tube resistance was able to be confirmed through investigation of the returned device.The customer returned one 14fr manta device, one 14fr sheath, and one depth locator.Signs of use were observed.Visual analysis revealed that the button valve was displaced and partially torn.This damage is consistent with bypass tube resistance.Functional testing revealed moderate resistance when advancing the bypass tube into the sheath.The additional information received indicates that severe resistance was experienced during bypass tube advancement.No structural damage or buckling of the sheath was observed.No medical intervention was required.A device history record review was performed, and a relevant finding of bypass resistance was 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 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: 22518003
• Report Number: 3010252479-2025-00075
• Device Sequence Number: 9231382
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)240501(17)251101(10)73E2400012(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/25/2025

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: 11/01/2025
• Device Catalogue Number: 2156
• Device Lot Number: 73E2400012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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 Age: 68 YR
• Patient Sex: Unknown
• Patient Weight: 103 KG