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

Model Number 2156

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Diminished Pulse Pressure (2606)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).An investigation has been opened to review historical data and risk documentation a follow up report will be submitted after investigation.

Event Description

It was reported that: "absent pulses after manta deployment." additional information has been requested from the account and the complaint will be re-reviewed on receipt.

Event Description

It was reported that: "absent pulses after manta deployment." additional information has been requested from the account and the complaint will be re-reviewed on receipt.

Manufacturer Narrative

(b)(4).The device was not returned for investigation.No return product evaluation could be completed.The device lot history record review indicated during lot release of manta lot, a single device exhibited a high collagen deployment force of the collagen deployment specification.No other non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.Based on the information submitted, following an undisclosed procedure, a 14f manta was deployed for closure.Absent pulses were present post-closure, although the procedure outcome was reported as completed with this device.After multiple unsuccessful attempts to obtain further information for this investigation, the root cause of this occlusion cannot be determined due to the insufficient information submitted for investigative purposes.The manta instructions for use lists potential adverse events related to the deployment of vascular closure devices including ischemia of the leg or stenosis of the femoral artery.

• Brand Name: MANTA 14F
• Type of Device: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16769325
• MDR Text Key: 313582747
• Report Number: 3010252479-2023-00077
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: 00856279007079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2024
• Device Model Number: 2156
• Device Catalogue Number: 2156
• Device Lot Number: MN2201481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Age: 75 YR
• Patient Sex: Female