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

Catalog Number	2156
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the manta would not advance through sheath." the issue was identified during use on patient.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the manta would not advance through sheath." the issue was identified during use on patient.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).One unit of manta, sheath and dilator were returned for evaluation.Blood particulates were noted on all of them.The units were dec ontaminated and inspected.Manta was locked into the sheath with the lever actuated.The components were not pushed out of the lumen.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.Customer stated, "manta would not advance through sheath".Per product return, the manta was locked into the sheath.It is likely that the customer could have experienced a severe resistance in advancing the bypass tube.No confirmation on the degree of resistance experienced was provided.Functional testing for resistance cannot be performed due the manta locked into the sheath.The ifu states the following if significant resistance is felt inserting the bypass tube into the manta sheath, remove the entire system and open a new device.A capa was 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.The corrective action within the capa led to a decrease of the issue by 50% rate and further investigations 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.

• 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: 19040458
• Report Number: 3010252479-2024-00051
• Device Sequence Number: 8482966
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: 00856279007079
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/11/2024

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
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/09/2024
• 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