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

Catalog Number	2115
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "customer notified me that the 8 fr depth locator broke off during insertion and the broken piece could not be retrieved.The patient was reported as fine.".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).Additional information states that a portion of the device was left in the patient, and they were unable to retrieve it so they stented it to the wall of the vasculature.The initial was already sent as a device malfucntion.This information changes the complaint to a serious injury.No return product evaluation could be completed as the device was not returned for investigation.A photo of the damaged 8f depth locator was obtained.Blood particulates were noted on the 8f puncture locator and 18f introducer.The break on the 8f depth locator appears to occur at the blood holes proximal to the first laser marking measurement.The device lot history record review for lot number 73c2400113 was performed, and no relevant findings were identified.Case details were reviewed.After an evar procedure, an 18f manta device was planned for closure.Access was obtained using a micropuncture kit with ultrasound guidance.Scar tissue was observed in the right common femoral arteriotomy from a previous surgery.Due to this scar tissue, the depth locator partially broke off during insertion and could not be retrieved.The physician proceeded with manta deployment to the measured depth, achieving immediate hemostasis.After deployment, a covered stent was inserted across the artery to secure the broken piece of the depth locator.The patient experienced no injury or harm, and the post-procedure outcome was successful.The patient was discharged in stable condition.The manta instructions for use warns against using the manta device in cases where there is difficulty dilating the femoral artery during initial access and stepwise dilation to accommodate the large-bore device.Difficulties in dilating the puncture tract, particularly due to scar tissue, may cause surrounding tissue swelling, which can compromise the accuracy of the puncture depth measurement during the depth location procedure.The root cause of the device being damaged during use is potentially attributed to user error due to poor patient selection.The depth locator was unable to retract from the patient due to the scar tissue present.
Event or Problem Description
It was reported that: "customer notified me that the 8 fr depth locator broke off during insertion and the broken piece could not be retrieved.The patient was reported as fine.".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20461587
• Report Number: 3010252479-2024-00173
• Device Sequence Number: 15402145
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240305(17)250905(10)73C2400113(21)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73C2400113
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2024
• 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 Sex: Unknown