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

Model Number	G407208
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atypical flutter for a congenital heart (tridux surgery), the aorta was perforated.The introducer was removed, patient remained stable, and the procedure was completed.During the transseptal puncture, the aorta was perforated.Fluoroscopy confirmed the guidewire and dilator tip were in the aorta 1cm above the aortic valves.Cardiothoracic surgeons were called to advise.Structural abnormalities of the heart associated with previous surgical procedures cause the reflux to occur between the aorta and the right atrium and not towards the pericardium.The medical team decided to remove the sheath and guide.The patient's blood pressure was stable so the procedure was completed.Protamine was administered and the patient was transferred to the recovery room.The patient has since been discharged.There were no reported performance issues with any abbott device.
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.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.

• Brand Name: BRK¿ 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18977725
• Report Number: 3008452825-2024-00158
• Device Sequence Number: 6497724
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: 05414734205139
• 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): 04/19/2024

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: G407208
• Device Lot Number: 10199961
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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