MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 18F; VASCULAR CLOSURE DEVICE

Catalog Number	2115
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "post tavr procedure, manta sheath was inserted.Physician met severe resistance advancing bypass tube through the manta sheath valve.Several attempts were made to advance the bypass tube to the sheath valve in order to advance the handle down to the sheath.Finally, the manta went through the valve of the sheath.He then met severe resistance to snap the manta device to the manta sheath.Several attempts were made to forcibly snap the two pieces together but ultimately were unsuccessful.The unit was removed intact and bagged to be sent back for investigation.A new manta sheath and device were inserted and deployed without issues.No medical intervention required".
Additional Manufacturer Narrative
(b)(4).One unit of manta and sheath were returned for evaluation.Blood particulates were noted on the unit.Units were decontaminated and inspected.Button valve was slightly displaced from its original position.Case details were reviewed.A 73-year-old female patient (66kgs.), presented in the or for a tavr procedure.A centrally positioned access was gained utilizing a micro puncture kit with ultrasound for guidance.No issues were encountered advancing or withdrawing the 14f expandable procedural sheaths during the case.Following the tavr, an 18f manta was deployed 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.No kinking occurred to the bypass tube when met with resistance.After several attempts to advance the bypass tube, the handle unit went through the hemostatic valve to advance the manta handle closure down to the sheath hub.The physician encountered severe resistance while connecting the handle unit to the sheath hub.The physician continued applying force and after several attempts was unsuccessful in connecting the manta device to the sheath hub.The first 18f manta device and sheath were removed, a new 18f manta device and sheath were loaded and deployed without issue and the patient outcome post-procedure was fine.The manta instructions for use (ifu) indicates in step 3 of inserting the device: note: if significant resistance is felt insert the bypass tube into the manta sheath, remove the entire system, and open a new device.The occurrence rate for similar events regarding manta-difficulty advancing delivery system tube is 0.000%.We will continue to monitor the rate for all ders and only initiate a new nce if it exceeds (b)(4) the der process will continue to monitor for any similar events.
Additional Manufacturer Narrative
Qn#(b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that: "post tavr procedure, manta sheath was inserted.Physician met severe resistance advancing bypass tube through the manta sheath valve.Several attempts were made to advance the bypass tube to the sheath valve in order to advance the handle down to the sheath.Finally, the manta went through the valve of the sheath.He then met severe resistance to snap the manta device to the manta sheath.Several attempts were made to forcibly snap the two pieces together but ultimately were unsuccessful.The unit was removed intact and bagged to be sent back for investigation.A new manta sheath and device were inserted and deployed without issues.No medical intervention required".

• Brand Name: MANTA 18F
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20924507
• Report Number: 3010252479-2024-00191
• Device Sequence Number: 12039052
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240423(17)251025(10)73D2401021(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 11/20/2024

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 Expiration Date: 10/23/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73D2401021
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2024
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 66 KG