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

Catalog Number	2115
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "after footplate deployment the device fell apart, and malfunctioned.Dr preformed surgical cutdown to fix." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 8mm with no reported calcification or tortuosity.Measured depth for the manta was 5+1cm.Both protamine and heparin were administered intravenously during the procedure.Dr stated that as he was pulling to tension , the device failed and came apart.Time to hemostasis was immediate but after angiogram they noticed an occlusion and no distal pulses.Cut down preformed and device removed patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).The report that the manta sheath separated from the housing was confirmed through visual analysis of the returned sample and pictures provided by the customer.The customer returned one 18fr manta closure device with the associated packaging for investigation.Visual analysis revealed that the sheath was separated from the sheath housing.The wings on the hub of the sheath were visibly stretched and deformed.There was no visual damage on the bypass tube and the button valve was torn as expected.Dimensional analysis was done on the sheath, sheath housing, and button valve.All relevant measurements were within specification limits except the distance between the wings on the blue hub of the sheath which measured 17.23 mm which is below the specification limit.This is likely due to excess force on the sheath hub from separation.The returned sheath was reassembled with the button valve and housing.The connection was then tested and was securely attached.Additional information provided by the customer reported that the tension gauge was not working when the suture was being pulled.The device was disassembled, and the suture was pulled which engaged the tension gauge.Therefore, we were not able to confirm that report.A review of the manufacturing process confirmed that these devices undergo 100% inspection and evaluation, as part of the product release criteria.A device history record review was performed, and no relevant findings were identified.Based on the customer report, sample received, and manufacturing processes, the root cause of this event cannot be determined.Teleflex will continue to monitor and trend for events of this nature.
Event or Problem Description
It was reported that: "after footplate deployment the device fell apart, and malfunctioned.Dr preformed surgical cutdown to fix." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 8mm with no reported calcification or tortuosity.Measured depth for the manta was 5+1cm.Both protamine and heparin were administered intravenously during the procedure.Dr stated that as he was pulling to tension , the device failed and came apart.Time to hemostasis was immediate but after angiogram they noticed an occlusion and no distal pulses.Cut down preformed and device removed patient was reported as fine post the procedure.".

• 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: 22211811
• Report Number: 3010252479-2025-00066
• Device Sequence Number: 20987699
• 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: 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 06/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown
• Patient Weight: 87 KG