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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "manta used per ifu.81y/o male.Bmi of 35.Depth location was 6.5+1cm.Mild posterior calcium, but vessel was 8.9mm.Access of rca via u/s.Blood pressure 130mmhg, act 220.Heparin 10000 units and half dose protamine given prior to closure.Pre-dilation of aortic valve with 18fr sheath, then removed and procedure completed with medtronic integrated system.Manta inserted and pulled to 7.5cm and fully deployed post procedure.Bleeding still noted post procedure, but no hematoma.Upon post manta cine, extravasation noted near the manta device.Manual pressure held and we went up and over with balloon.With balloon inflated, bleeding at access site still noted.Balloon inflated to nominal and kept up for 5 minutes.2 covered stents deployed.Strong ooze at access site still noted and held pressure for 30min.Vascular surgeon stated he believed the manta is not the culprit and there is a vessel issue.Bleeding slowed and patient was taken to icu for further manual pressure and observation.Some hours later, bleeding stopped and no noted oozing or hematoma, and rp bleed was ruled out.Patient was stable and on bed rest.Patient was discharged the next day.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The details of the complaint including photos and videos of fluoroscopic imaging were reviewed.A device history record review was performed, and no relevant findings were identified.Based on the information available, the probable cause is likely due to a vessel issue and not manta related.Without the device to evaluate, the root cause could not be conclusively determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "manta used per ifu.81y/o male.Bmi of 35.Depth location was 6.5+1cm.Mild posterior calcium, but vessel was 8.9mm.Access of rca via u/s.Blood pressure 130mmhg, act 220.Heparin 10000units and half dose protamine given prior to closure.Pre-dilation of aortic valve with 18fr sheath, then removed and procedure completed with medtronic integrated system.Manta inserted and pulled to 7.5cm and fully deployed post procedure.Bleeding still noted post procedure, but no hematoma.Upon post manta cine, extravasation noted near the manta device.Manual pressure held and we went up and over with balloon.With balloon inflated, bleeding at access site still noted.Balloon inflated to nominal and kept up for 5 minutes.2 covered stents deployed.Strong ooze at access site still noted and held pressure for 30min.Vascular surgeon stated he believed the manta is not the culprit and there is a vessel issue.Bleeding slowed and patient was taken to icu for further manual pressure and observation.Some hours later, bleeding stopped and no noted oozing or hematoma, and rp bleed was ruled out.Patient was stable and on bed rest.Patient was discharged the next day.".

• 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: 22202434
• Report Number: 3010252479-2025-00063
• Device Sequence Number: 17813042
• 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: FL
• 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: 07/02/2025
• 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: 81 YR
• Patient Sex: Male