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

Catalog Number	2156
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "sheath advanced smoothly on super core wire.14f manta device advanced over wire.Bypass tube would not fully engage into valve of sheath.Device became kinked in two areas.Advised it be removed and replaced.Second manta device used same lot number with no concerns.Deployed with hemostasis achieved.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "sheath advanced smoothly on super core wire.14f manta device advanced over wire.Bypass tube would not fully engage into valve of sheath.Device became kinked in two areas.Advised it be removed and replaced.Second manta device used same lot number with no concerns.Deployed with hemostasis achieved.".
Additional Manufacturer Narrative
(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 mn2301556 manta 14f indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications before shipment.Case details were reviewed.Following the paravalvular leak closure, a 14f manta was deployed for closure.While inserting the bypass tube through the hemostatic valve of the manta sheath, the physician encountered moderate resistance attempting to advance the bypass tube into the sheath hub.The bypass tube would not enter the hemostatic valve.Buckling and bending occurred to the bypass tube when resistance was met.The first 14f manta device and sheath were removed and a second 14f manta device and sheath (same lot number) were opened and deployed, achieving hemostasis.A capa was previously opened under teleflex quality system to address this issue.Based on the investigation, the root cause has been determined to be manufacturing related.Further investigation related to this event will be initiated if the occurrence rate exceeds the limit as per the capa.The der process will continue to monitor for any similar events.

• Brand Name: MANTA 14F
• 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: 20395222
• Report Number: 3010252479-2024-00165
• Device Sequence Number: 6425690
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: (01)00856279007079(11)231012(17)250430(10)MN2301556(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/23/2024

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: 04/30/2025
• Device Catalogue Number: 2156
• Device Lot Number: MN2301556
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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: 86 YR
• Patient Sex: Unknown
• Patient Weight: 104 KG