MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 14F; 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	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during a pci / impella removal, getting the bypass tube in the sheath valve was difficult, the doctor was able to click to closure unit into the sheath with more force than usual.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
(b)(4).Correction to section d: udi number.Additional information: no return product evaluation could be completed as the device was not returned for investigation.The device lot history record review for lot number mn2301565 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 protected pci/impella removal, a 14f manta was deployed to the measured depth for closure.While inserting the bypass tube through the hemostatic valve of the manta sheath, the physician encountered moderate to severe resistance attempting to advance the bypass tube into the sheath hub.No structural damage on the lumen of the sheath and no buckling or bending occurred to the bypass tube when resistance was met.While using more force than usual, the physician was able to get the bypass tube in the sheath valve and clicked the closure unit into the sheath.Closure was completed with this device.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 manufacturing related.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: "during a pci / impella removal, getting the bypass tube in the sheath valve was difficult, the doctor was able to click to closure unit into the sheath with more force than usual.There was no reported 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: 20395932
• Report Number: 3010252479-2024-00161
• Device Sequence Number: 7842587
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)230105(17)250515(10)MN2301565(21)
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (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): 09/18/2024

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: MN2301564
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/11/2024
• 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: Unknown