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

Catalog Number	2115
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "limited flow noted past the access site after manta deployment." additional information: "during a tavr, micro puncture and ultrasound were utilized to gain access in the mid femoral head of the right common femoral artery.Vessel size 9.6cm.Advancing procedure sheaths during the case was difficult.Shockwave was used in the distal aorta just above the bifurcation to advance the valve deployment device.Calcification as mild above the access site.Measured depth for the manta was 8+1mm.Act was 250.18000units of heparin and 40mg of protamine were given during the procedure.After the occlusion was noted, a balloon angioplasty of the area was done and flow was restored.The patient was reported as fine post the procedure.".
Event or Problem Description
It was reported that: "limited flow noted past the access site after manta deployment." additional information: "during a tavr, micro puncture and ultrasound were utilized to gain access in the mid femoral head of the right common femoral artery.Vessel size 9.6cm.Advancing procedure sheaths during the case was difficult.Shockwave was used in the distal aorta just above the bifurcation to advance the valve deployment device.Calcification as mild above the access site.Measured depth for the manta was 8+1mm.Act was 250.18000units of heparin and 40mg of protamine were given during the procedure.After the occlusion was noted, a balloon angioplasty of the area was done and flow was restored.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of limited flow past the manta access site was confirmed by visual inspection of the customer supplied photos.However, full complaint verification testing could not be performed as no sample was returned for analysis.The details of the complaint were reviewed, and it was confirmed that collagen was not deployed in the vessel, the anchor was positioned correctly, and there was no dissection of the vessel.There was mild calcification above the access site but not at the access site.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports 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: 22201862
• Report Number: 3010252479-2025-00062
• Device Sequence Number: 7714043
• 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: MS
• 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): 05/20/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 75 YR
• Patient Sex: Unknown
• Patient Weight: 127 KG