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

Catalog Number	2156
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "unable to get manta device through the manta valve.Entire device was discarded and successfully used a new device." additional information: the case was an evar.The manta was used to close the left cfa.Severe resistance was met when attempting to pass the device through the sheath.The patient was reported as fine post the procedure.".
Additional Manufacturer Narrative
Qn#(b)(4).One unit of manta was returned for evaluation.Blood particulates were noted on the unit.Unit was decontaminated and inspected.Lever of the manta was not actuated.The lumen of the manta was severely kinked.No sheath was returned.The top-level assembly traveler (lot mn2301481) was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.One unit of manta(14f) was returned for evaluation.Lever of the manta was not actuated.The lumen of the manta was severely kinked.No sheath was returned.As per the additional information received, severe resistance was observed by the user when attempting to advance the bypass tube/manta.The damage to the lumen is likely due to the user attempting to advance against resistance.The ifu states the following note: - if significant resistance is felt inserting the bypass tube into the manta sheath, remove the entire system and open a new device.A manufacturing record review was completed, and no issues were observed.A capa was previously opened under teleflex quality systems to address this issue.The root cause is identified as 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 investigations will be only initiated if the occurrence rate exceeds the limit as per the capa.
Event or Problem Description
It was reported that: "unable to get manta device through the manta valve.Entire device was discarded and successfully used a new device." additional information: the case was an evar.The manta was used to close the left cfa.Severe resistance was met when attempting to pass the device through the sheath.The patient was reported as fine post the procedure.".

• Brand Name: MANTA 14F
• 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: 18985089
• Report Number: 3010252479-2024-00047
• Device Sequence Number: 11477729
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: 00856279007079
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/01/2024

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: MN2301481
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown