MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR

Model Number	G407209
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Thrombosis/Thrombus (4440)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a mitraclip procedure, a pericardial effusion occurred which required a pericardiocentesis to stabilize the patient.The transseptal puncture was performed and a steerable guide catheter (sgc) was inserted and advanced to the mitral valve.A transesophageal echocardiogram (tee) was performed which revealed a thrombus and a pericardial effusion.Heparin was administered to treat the thrombus.A pericardiocentesis was performed to treat the pericardial effusion.The sgc was removed, and the procedure was discontinued.There was no clinically significant delay in the procedure.The patient does not have a preexisting history of thrombus and a pre-procedure tee performed was negative.The physician does not know what caused the thrombus.There were reported performance issues with any abbott device.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.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: BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Common Device Name: TROCAR
• Manufacturer (Section D): ST. JUDE 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): ST. JUDE 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20776903
• Report Number: 3008452825-2024-00687
• Device Sequence Number: 11852474
• Product Code: DRC
• UDI-Device Identifier: 05414734205184
• UDI-Public: (01)05414734205184(10)10417010(17)270630
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/08/2025

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
• Device Model Number: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 10417010
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown