MAUDE Adverse Event Report: ABBOTT MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES; TROCAR

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/10/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Model/lot number information was not able to be obtained for this device.Therefore, full udi information(d4) and 510k(g3) are not available.
Event or Problem Description
During a mitraclip procedure, the patient developed a pericardial effusion and expired.The procedure was performed to treat functional mitral regurgitation (mr) grade 4+.A triclip steerable guide catheter (tsgc) was used off-label with the mitraclip clip delivery system (cds) as it was also planned to treat tricuspid regurgitation (tr) grade 3-4 after the mr.Patient was frail but stable.Initial steering to the mitral valve was difficult due to prominent coumadin ridge.During initial steering to the mitral valve a drop of blood pressure was noticed and echocardiographer confirmed circumferential pericardial effusion.Location was unknown as bleeding spread quickly.Physician concluded cardiac tamponade was present.Protamine administered.Patient turned hemodynamically unstable.Pericardiocentesis was performed as the tsgc and cds were removed.Pericardiocentesis was unsuccessful and the patient's condition worsened.Due to this, open heart surgery was performed.After initial improvement with ecmo, the patient's condition diminished and could not be stabilized.After several unsuccessful attempts to resuscitate the patient died.It was thought the pericardial effusion was due to transseptal puncture and was unrelated to the mitraclip system.There were difficulties with the transseptal puncture due to challenging anatomy and poor visualization on echo.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the ifu, cardiac tamponade and pericardial effusion are known risks during the use of this device.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Common Device Name: TROCAR
• Manufacturer (Section D): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ABBOTT MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23388095
• Report Number: 3008452825-2025-00498
• Device Sequence Number: 9970043
• Product Code: DRC
• UDI-Device Identifier: 05414734205122
• UDI-Public: 05414734205122
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/26/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Unknown