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

Catalog Number	2156
Medical Device Problem Codes	Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "dr.Had trouble inserting the bypass tube into the sheath, he eventually got it in, but it took a lot of effort.".
Event or Problem Description
It was reported that "dr.Had trouble inserting the bypass tube into the sheath, he eventually got it in, but it took a lot of effort.".
Additional Manufacturer Narrative
Qn#(b)(4).One unit of manta, sheath and dilator were returned for evaluation.The manta was locked within the housing of the sheath.Blood particulates were noted on all units.The units were decontaminated and inspected.No components (collagen, sheath and lock) were present.The unit was dismantled to expose the sheath and valve.The button valve was torn and displaced slightly from its original position.The device lot history record review for lot number 73c2400437 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.A 73-year-old male patient (68 kgs) presented in the or for a ventricular assist device (vad) removal.A centrally positioned access was gained utilizing micropuncture with ultrasound for guidance.The arteriotomy was clear of calcification and tortuosity.No issues were encountered advancing or withdrawing the impella abiomed procedural sheath during the case.Following the vad, a 14f 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 buckling or bending to the bypass tube, and no structural damage on the lumen of the sheath occurred when resistance was met.The physician was able to get the bypass tube halfway into the sheath valve and clicked the closure unit into the sheath, although it was very difficult.Closure was completed with this device and the patient's current condition is fine.A capa was previously opened under teleflex quality system to address this issue.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.

• 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: 20381656
• Report Number: 3010252479-2024-00162
• Device Sequence Number: 17746459
• Product Code: MGB
• UDI-Device Identifier: 10856279007328
• UDI-Public: (01)10856279007328(11)240312(17)250912(10)73C2400437(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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 09/12/2025
• Device Catalogue Number: 2156
• Device Lot Number: 73C2400437
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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: Unknown
• Patient Weight: 68 KG