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

Catalog Number	2156
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "manta device deployed in tissue tract failure to obtain hemostasis".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).No product evaluation could be completed as the product was not returned for evaluation.The device lot history record reviews for lot numbers mn2301498 manta 14f indicated no non-conformities related to these lots, therefore, supporting the devices met material, assembly, and performance specifications before shipment.Case details were reviewed.A patient (female 68y, 91kgs) underwent a protected pci.Customer stated," manta device deployed in tissue tract failure to obtain hemostasis." as per the additional information received, the procedure sheath was impella.Access site was right cfa.Vessel size was 8 mm.Vessel was severely calcified with posterior and mid wall calcification.Manta (14f) was deployed at 4.5+1 cm.The ifu along with the product states: do not use if the patient has marked obesity or cachexia (bmi >40 kg/m2 or < 20kg/m2) - do not use in patients with severe calcification of the access vessel no issues noted with procedural sheaths.Act is unknown.Heparin and protamine were administered.Per ifu, the potential adverse events related to the deployment of vascular closure devices include other access site complications leading to bleeding, possibly requiring surgical repair, and/or endovascular intervention.The ifu precautions, if bleeding from the femoral access site persists after using the manta device, assess the situation.Based on the amount of bleeding, use manual or mechanical compression, application of balloon pressure, placement of a covered stent, and/or surgical repair to obtain hemostasis.Vessel was treated with viabhan covered stent.Extravasation was noted in the customer supplied pictures.The lock was observed to be farther from the vessel indicative that the deployment was not performed at the correct depth.Also, the ifu states the following: - before deploying the device and releasing the anchor, position the manta closure and sheath according to the deployment depth noted in 'step 1: arteriotomy locating procedure.' grasp the manta delivery handle and slowly withdraw the manta closure and sheath until the depth marking appears that corresponds to the deployment depth noted during step 1.The manta closure is now in deployment position and ready for anchor release.Note: do not re-advance the manta closure and sheath deeper into the vessel if they are withdrawn past the deployment depth.If this occurs prior to rotating the lever, remove the entire system and open a new device.A manufacturing record review was completed for lot mn2301498.No nonconformities were observed.Based on the information, the most likely root cause of the issue is user error.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported "manta device deployed in tissue tract failure to obtain hemostasis".The patient's current condition is reported as "fine".

• Brand Name: 14F MANTA VASCULAR CLOSURE DEVICE
• 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: 19164450
• Report Number: 3010252479-2024-00061
• Device Sequence Number: 20797374
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: 00856279007079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 03/27/2024

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
• Device Catalogue Number: 2156
• Device Lot Number: MN2301498
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NONE REPORTED; NONE REPORTED
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 91 KG