MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ 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	Cardiac Perforation (2513)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During an atrial fibrillation procedure, there was a pericardial effusion.At the beginning of the procedure, the tactisys quartz did not read the contact force, and no reset was possible.When the first tacticath se catheter was connected, prior to insertion into the patient, the contact force information was still unavailable.The tacticath se catheter was exchanged, but the issue was did not resolve.The procedure was then continued with the second tacticath se catheter, despite having no contact force information.Mapping was started with an inquiry afocus mapping catheter but was being finished in the left atrium with the tacticath se catheter when the transseptal access was lost and the tacticath se catheter was back in the right atrium.The patient became hypotensive, and a transesophageal echocardiogram was performed showing a pericardial effusion.The pericardial effusion was noted on the anterior part of the heart between the right and left atrium.No intervention was administered as the pericardial effusion spontaneously resolved on its own.The physician alleges that the perforation occurred during transseptal puncture with the brk transseptal needle or when maneuvering the tacticath se catheter.No ablation was performed.The patient remained stable and was discharged.
Additional Manufacturer Narrative
Additional information: d4, g3, h2, h3, h6, h11.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 pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.

• Brand Name: BRK¿ 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19986832
• Report Number: 3008452825-2024-00454
• Device Sequence Number: 14546481
• Product Code: DRC
• UDI-Device Identifier: 05414734205139
• UDI-Public: 05414734205139
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/06/2024

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 Catalogue Number: G407208
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE.
• Patient Sex: Unknown