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

Catalog Number	2156
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "manta device completely came out of patient when trying to deploy.Physician used a new manta and added 1cm and deployment was successful." ai received on 01nov2024: "severe resistance was experienced with advancement of the manta bypass tube into the manta sheath.It was also reported that there was buckling and bending of the bypass tube.Ai received on 07nov2024: it was confirmed that there was kinking of the first bypass tube when it met resistance.When the manta completely pulled out of the patient, the anchor was inside the sheath.The patient experience no harm or consequence.".
Additional Manufacturer Narrative
(b)(4).One unit of manta, depth locator and dilator were returned for evaluation.Blood particulates were noted on the unit.Unit was decon taminated and inspected.Manta was locked into the sheath.The lever was actuated.The components (collagen, lock and footplate) were not pushed out.Unit was dismantled to expose the button valve.The button valve was slightly displaced and torn.The device lot history record review for lot number mn2401572 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.Following the tavr, a 14f manta was planned for closure.While inserting the bypass tube through the hemostatic valve of the manta sheath, the physician encountered severe resistance attempting to advance the bypass tube into the sheath hub.When resistance was met, buckling, bending, and kinking occurred to the bypass tube, although no structural damage occurred to the lumen of the sheath.The manta device completely came out of the patient while attempting to deploy.The physician replaced the first 14f manta device and sheath with a second 14f manta device and sheath (same model and lot number).While deploying the second manta the physician added 1cm to the measured deployment depth and completed closure.The patient did not experience any harm, or consequence from this event and the outcome post-procedure was fine.A capa was previously opened under teleflex quality system to address this issue.Based on the investigation, the root cause has been determined to be lack of production and process controls that led to a shift in button valve performance.Further investigation related to this event 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: "manta device completely came out of patient when trying to deploy.Physician used a new manta and added 1cm and deployment was successful." ai received on 01nov2024: "severe resistance was experienced with advancement of the manta bypass tube into the manta sheath.It was also reported that there was buckling and bending of the bypass tube.Ai received on 07nov2024: it was confirmed that there was kinking of the first bypass tube when it met resistance.When the manta completely pulled out of the patient, the anchor was inside the sheath.The patient experiance no harm or consequence.".

• Brand Name: 14F MANTA
• 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: 20723283
• Report Number: 3010252479-2024-00184
• Device Sequence Number: 17764731
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)240215(17)250815(10)MN2401572(21)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 08/31/2025
• Device Catalogue Number: 2156
• Device Lot Number: MN2401572
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 105 KG