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

Catalog Number	2115
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "the manta depth locator split in half trying to remove from the vessel after depth location due to severe scar tissue left from a hip replacement." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 8mm with mild calcification.The manta was not used on this patient.The depth locator broke in half and so we were not able to use the product.We had to retrieve the distal half of the depth locator that was in the patient.This resulted in a cut down.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).One unit of depth locator was returned for evaluation.Blood particulates was noted on the unit.The unit was decontaminated and ins pected.The lumen of the depth locator was split into two separate pieced.The polymer was observed to be stretched at the junction of separation.The device lot history record review for lot number 73d2400021 manta 18f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.An 84-year-old female patient presented in the or for a tavr procedure.After multiple attempts, centrally positioned access was gained utilizing ultrasound guidance with a micropuncture kit.The right common femoral arteriotomy was 8mm, with mild calcification.Following the tavr, an 18f manta was planned for closure.After performing depth location, while attempting to remove the depth locator, due to severe scar tissue present from a hip replacement, the depth locator broke in half.Surgical intervention was required to retrieve the distal portion of the depth locator located within the patient.The manta instructions for use (ifu) posts warning to not use manta if there is difficult dilation from initial femoral artery access while step dilating up to the large-bore device.Difficult dilation of the puncture tract due to scar tissue may lead to swelling of surrounding tissue, thus compromising the accuracy of the puncture depth determined during the depth location procedure.The root cause of the device being damaged during use is likely contributed to user error due to poor patient selection.The depth l ocator was unable to retract from the patient due to the severe scar tissue present.
Event or Problem Description
It was reported that "the manta depth locator split in half trying to remove from the vessel after depth location due to severe scar tissue left from a hip replacement." additional information: "during a tavr procedure, micro puncture and ultrasound were utilized to gain central access in the right common femoral artery.Vessel size was 8mm with mild calcification.The manta was not used on this patient.The depth locator broke in half and so we were not able to use the product.We had to retrieve the distal half of the depth locator that was in the patient.This resulted in a cut down.".

• 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: 20405999
• Report Number: 3010252479-2024-00166
• Device Sequence Number: 19670847
• Product Code: MGB
• UDI-Device Identifier: 00856279007307
• UDI-Public: (01)00856279007307(11)240401(17)251001(10)73D2400021(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/25/2024

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: 10/01/2025
• Device Catalogue Number: 2115
• Device Lot Number: 73D2400021
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: 84 YR
• Patient Sex: Unknown