MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. 14F MANTA VASCULAR CLOSURE DEVICE

Catalog Number	2156
Medical Device Problem Codes	Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the customer returned one 14fr manta device for analysis.Signs of use were observed.Visual inspection revealed the footplate was protruding from the bypass tube.The manta lever was not actuated.Damage was observed on the sheath body, and the button valve was displaced from its intended position.The valve was pushed further into the sheath, near the area of observed body damage.Dimensional testing was completed per the button valves product drawing.The button valve was removed from the sheath and measured.The outer diameter specification limit is 15.7 mm - 16.1 mm.The button valve outer diameter measured 15.80 mm, which is within specification limits.The width specification limit is 3.2 mm - 3.6 mm.The button valve width measured 3.33 mm , which is within specification limits.Functional testing could not be performed as the button valve was displaced.The sheath was disassembled and the button valve was dislodged; however, the sheath could not be reassembled to the original condition for functional testing.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "note: if significant resistance is felt inserting the bypass tube into the manta sheath, remove the entire system and open a new device." the complaint of bypass tube resistance was confirmed through investigation of the returned sample.Visual analysis revealed the footplate was protruding from the bypass tube.The manta lever was not actuated.Damage was observed on the sheath body, and the button valve was displaced from its intended position.The valve was pushed further into the sheath, stuck near the area of observed body damage.The displacement of the button valve was likely caused by pushing against excessive resistance during insertion of the bypass tube into the sheath.Furthermore, this likely caused the footplate to protrude and damage the body of the sheath.Dimensional testing of the button valve passed.A device history record review was performed, and no relevant findings were identified.A capa was previously initiated for bypass tube resistance that was attributed to a supplier manufacturing deficiency.Corrections were implemented.Based on information received from the customer, the most likely root cause for the bypass tube resistance is supplier related.Use error likely contributed to the damage seen on the manta sheath.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that, "the first 14f manta device was partially inserted into the sheath, at which point resistance was encountered.It was observed that the footplate was exposed outside of the bypass tube.A second 14f manta device was subsequently opened, and the operator utilized the existing first manta sheath for insertion.The same issue occurred, with resistance encountered during insertion and the footplate again observed to be exposed outside of the bypass tube.The entire manta system was then removed from the guidewire, at which time a hole was identified in the first manta sheath.A third 14f manta device was opened and successfully deployed without further issue." there were no reports of patient injury, harm, or adverse health consequences associated with the event.The patient's condition was reported as fine.No medical intervention was necessary.

• Brand Name: 14F MANTA VASCULAR CLOSURE DEVICE
• 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: angela meister ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 25083258
• Report Number: 3010252479-2026-00016
• Device Sequence Number: 21465915
• Product Code: MGB
• UDI-Device Identifier: 10841156111359
• UDI-Public: (01)10841156111359(11)251015(17)270415(10)73K2500622(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
• Report Date (Section B): 04/13/2026

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: 73K2500622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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 Age: 84 YR
• Patient Sex: Female