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

Catalog Number	2115
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "partial occlusion of femoral artery, artery ballooned for 30 seconds and occlusion resolved." additional information: "during an lbc procedure, micro puncture and ultrasound were utilized to gain lower access in the common femoral artery.There was no reported calcification or tortuosity.Measured depth for the manta was 2+1.Time to haemostasis was immediate.There was no patient injury or consequence from the procedure.".
Additional Manufacturer Narrative
Qn# (b)(4).Udi was be provided with the follow up report.
Additional Manufacturer Narrative
Qn# (b)(4).No return product evaluation could be completed as the device was not returned for investigation.The device lot history record review for lot number mn2401576 manta 18f ce indicated no non-conformities related to this lot, therefore supporting the device met material, assembly, and performance specifications before shipment.The case details were reviewed.A 79-year-old male patient (67 kgs) presented in the or for an lbc procedure.A lower-positioned access was gained utilizing a micropuncture kit and ultrasound for guidance.The arteriotomy was clear of calcification and tortuosity, with a measured deployment depth of 2.0cm + 1cm.There were no issues in advancing or withdrawing the procedural sheaths during the case.Following the lbc procedure, an 18f ce manta device was deployed to the measured depth, and hemostasis was immediate.A partial occlusion occurred in the femoral artery, balloon angioplasty was performed for thirty seconds, restoring flow.Due to insufficient information regarding the initial deployment, patient environment and conditions, and no angiograms or device submitted for this investigation, the cause of the occlusion requiring balloon angioplasty cannot be determined.Therefore, the root cause as to why the manta was ineffective in achieving hemostasis requiring percutaneous intervention remains undeterminable.There appears to be no product quality issue concerning manufacture, documentation or label ling.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "partial occlusion of femoral artery, artery ballooned for 30 seconds and occlusion resolved." additional information: "during an lbc procedure, micro puncture and ultrasound were utilized to gain lower access in the common femoral artery.There was no reported calcification or tortuosity.Measured depth for the manta was 2+1.Time to haemostasis was immediate.There was no patient injury or consequence from the procedure.".

• 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: 21650917
• Report Number: 3010252479-2025-00030
• Device Sequence Number: 9511241
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)240314(17)250914(10)MN2401576(21)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/26/2025

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: 09/30/2025
• Device Catalogue Number: 2115
• Device Lot Number: MN2401576
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2024
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 67 KG