MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	G407211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a persistent atrial fibrillation procedure in the left atrium, a pericardial effusion was noted, requiring a pericardiocentesis and surgery.The pulmonary veins were fully isolated with a tacticath se ablation catheter.The patient then became hypotensive, and a pericardial effusion was diagnosed via ultrasound.It is alleged that the perforation occurred during transseptal puncture.A pericardiocentesis was performed and the patient was transferred to another hospital, princess grace hospital, for cardiac surgery.During surgery, the perforation was found between the left veins in the left atrium.The patient is now stable.The physician alleges that the perforation occurred due to patient anatomy, such as a recess, but there was no scan to identify this prior to the procedure.
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 pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 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: 19644422
• Report Number: 3008452825-2024-00346
• Device Sequence Number: 6587662
• Product Code: DRC
• UDI-Device Identifier: 05414734205153
• UDI-Public: (01)05414734205153(10)10326751(17)270430
• 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): 08/21/2024

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: G407211
• Device Catalogue Number: G407211
• Device Lot Number: 10326751
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTICATH CONTACT FORCE ABLATION CATHETER, SE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown