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
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: device in question would not advance through the valve.Just got stuck on the valve.Additional information: during a pci procedure.There was no issue advancing or withdrawing the sheaths.There was no reported of patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device 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 that the device met material, assembly, and performance specifications before shipment.Case details were reviewed.No issues were encountered advancing or withdrawing the initial procedural sheaths.Following the pci procedure, an 18f ce 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.The entire manta sheath removed otw, and a new sheath was placed for the second manta deployment.The patient experienced no harm or health consequences due to the event.The patient outcome was reported as doing well post-procedure.The ifu indicates: 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 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.
Event or Problem Description
It was reported that: device in question would not advance through the valve.Just got stuck on the valve.Additional information: during a pci procedure.There was no issue advancing or withdrawing the sheaths.There was no reported of patient harm or consequence.

• 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: 19017917
• Report Number: 3010252479-2024-00049
• Device Sequence Number: 18183314
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: 00856279007079
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/10/2024
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 89 KG