MAUDE Adverse Event Report: TELEFLEX INCORPORATED MANTA; DEVICE, HEMOSTASIS, VASCULAR

Model Number	IPN923493
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of a transcatheter aortic valve replacement with edwards 23 mm s3 ultra via percutaneous right transfemoral approach.The cardiologist assisted by the cath lab tech was attaching the manta to the sheath, the manta clicked in place, and blood sprayed from the connection site onto the tech, ehs [(environmental, health, and safety)] protocols followed.The cardiologist was able to deploy the collagen and seal with no harm to the patient.

• Brand Name: MANTA
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 24245768
• Report Number: 24245768
• Device Sequence Number: 15540282
• Product Code: MGB
• UDI-Device Identifier: 10841156109929
• UDI-Public: (01)10841156109929
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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
• Device Model Number: IPN923493
• Device Catalogue Number: 2115
• Device Lot Number: 73A2500358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026