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

Catalog Number	2115
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Extravasation (1842); Obstruction/Occlusion (2422)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "post manta deployment there was noticeable slow in flow post angiogram with slight blushing.Patient was post tavr valve size 20 with 14f sheath removal.Sheath was "tight" per provider going in.Artery was 7.1mm right femoral artery.Micro puncture and ultra sound used for access.Single stick to right femoral artery mid femoral head.Depth was 3+1cm.Patient weight was 41.7kg.Mild tortuosity, with mild posterior calcification.Direct pressure was held.While left sheath exchanged for long 6f sheath.Wire and balloon advanced and site angioplasty.Post angiogram had timi 3 flow and no blushing.Sbp 120's/60's-70's prior to deployment.Act pre valve deployment was 269.5000units heparin and 50mg protamine were administered during the procedure.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.A review of angiogram revealed a medial positioned access and an occluded dissection proximal to the access site.The device lot history record review for lot number 73c2400113 manta 18f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.Following closure, blood flow was noticeably slow.No external bleeding was seen although a post-deployment angiogram revealed blushing.Manual pressure was held, and balloon angioplasty was applied to the site.A follow-up post-angiogram indicated no further blushing and flow had been restored.The patient did not experience any harm or health consequences due to this event, and the outcome post-procedure was stable.The root cause of the slowed flow likely is contributed to user error due to poor patient selection.There is believed to be no device failure.The procedure was completed with this manta device.
Event or Problem Description
It was reported that: "post manta deployment there was noticeable slow in flow post angiogram with slight blushing.Patient was post tavr valve size 20 with 14f sheath removal.Sheath was "tight" per provider going in.Artery was 7.1mm right femoral artery.Micro puncture and ultra sound used for access.Single stick to right femoral artery mid femoral head.Depth was 3+1cm.Patient weight was 41.7kg.Mild tortuosity, with mild posterior calcification.Direct pressure was held.While left sheath exchanged for long 6f sheath.Wire and balloon advanced and site angioplasty.Post angiogram had timi 3 flow and no blushing.Sbp 120's/60's-70's prior to deployment.Act pre valve deployment was 269.5000 units heparin and 50mg protamine were administered during the procedure.The 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: 20406001
• Report Number: 3010252479-2024-00168
• Device Sequence Number: 3351877
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240305(17)250905(10)73C2400113(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73C2400113
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 42 KG