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

Catalog Number	2115
Medical Device Problem Codes	Break (1069); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "physician broke suture line during deployment and pushed collagen in vessel.The operator pulled back the manta device after with excessive force and the suture broke.The vessel was pta (balloon inflations) and placement of a bms (bare metal stent).Post angiogram revealed patent blood flow." additional information: "during an ecmo arterial decannulation procedure.Micro puncture and ultrasound were utilised to gain access in the left common femoral artery.Vessel size was >7.5mm with no reported calcification or tortuosity.Measured depth for the manta was 5+1=6.Post manta deployment time to haemostasis was 15 minutes.Systolic bp was 105/55mmhg.Act was 189.There was no reported patient harm.They were reported as fine post the procedure.".
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only section d.4.-unique identifier (udi)# corrected to (b)(4).One unit each of the manta, sheath, dilator, and depth locator were returned for evaluation, all with visible blood particulates.The manta was locked into the sheath with the lever actuated, but no components (collagen, lock, or anchor) were present or returned.Angiography showed a lower-positioned radiopaque lock with occluded flow at the access site.Balloon angioplasty indicated partial dog-boning and a dissection inferior to the access.The device lot history record review for lot number 73b2400587 manta 18f indicated no non-conformities related to this lot.The case details from the clinical staff were reviewed.A 72-year-old female patient (306 lbs, 5 ft 4 in, 52 kg/m2) with a history of low ejection fraction and severe mitral valve disease underwent ecmo arterial decannulation in the or.The manta instructions for use (ifu) include a warning against use in patients with marked obesity (bmi >40 kg/m2).After ecmo, an 18f manta was deployed at the measured depth.During deployment, the physician applied excessive force while pulling back the device, causing the suture line to break and forcing the collagen into the vessel.Post-angio confirmed malpositioning and intraarterial collagen deployment, causing occlusion.Manual pressure was applied, followed by balloon angioplasty, and a bare metal stent was deployed.Hemostasis was achieved in 15 minutes, and the patient initially remained stable with no harm, injury, or health consequences due to this event.However, later that evening, the patient developed limb ischemia and hyperlactatemia.Despite vascular consultation, no intervention occurred before the patient expired early in the morning.The suspected root cause of the occlusion requiring stenting was user error due to excessive force on the device, leading to suture breakage and intraarterial collagen deployment.The physician believes that the patient's death was unrelated to the manta closure device.
Event or Problem Description
It was reported that: "physician broke suture line during deployment and pushed collagen in vessel.The operator pulled back the manta device after with excessive force and the suture broke.The vessel was pta (balloon inflations) and placement of a bms (bare metal stent).Post angiogram revealed patent blood flow." additional information: "during an ecmo arterial decannulation procedure.Micro puncture and ultrasound were utilised to gain access in the left common femoral artery.Vessel size was >7.5mm with no reported calcification or tortuosity.Measured depth for the manta was 5+1=6.Post manta deployment time to haemostasis was 15 minutes.Systolic bp was 105/55mmhg.Act was 189.There was no reported patient harm.They were reported as fine post 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: 21444258
• Report Number: 3010252479-2025-00015
• Device Sequence Number: 7874417
• Product Code: MGB
• UDI-Device Identifier: 10856279007304
• UDI-Public: (01)10856279007304(11)240219(17)250819(10)73B2400587(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): 02/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73B2400587
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 52 KG