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

Catalog Number	2156
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "could not push the manta through the valve".Additional information: during an percutaneous ventricular assist device pvad procedure.Micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.When they were unable to push the manta trough the valve another device was used to complete the procedure.Ther patient was reported as fine.Associated complaints: 3010252479-2024-00064.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4), no product evaluation could be completed as the product was not returned for investigation.The device lot history record review for lot number mn2301556 manta 14f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.As per the additional information received, the patient bmi is unknown.Access site was right cfa with a size of 7 mm.No calcification or tortuosity noted.Severe bypass tube resistance was observed by the user during advancement of the manta through the valve.Patient condition is fine.18f manta was used to complete the case.A manufacturing record review was completed.No issues observed.The reported complaint is associated with a capa previously opened under teleflex quality system to address this issue.The root cause is related to lack of production and process controls that led to a shift in button valve performance.With the corrective action, a decrease in 50% rate was noted.Further inv estigations will be initiated if the occurrence rate exceeds the limit as per the capa.The der process will continue to monitor for any similar events.
Event or Problem Description
It was reported that "could not push the manta through the valve".Additional information: during an percutaneous ventricular assist device pvad procedure.Micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 7mm with no reported calcification or tortuosity.When they were unable to push the manta trough the valve another device was used to complete the procedure.The patient was reported as fine.Associated complaints: 3010252479-2024-00064 and 3010252479-2024-00065.

• 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: 19228216
• Report Number: 3010252479-2024-00065
• Device Sequence Number: 12445699
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: 00856279007079
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2156
• Device Lot Number: MN2301556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/31/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Female