MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK TRANSSEPTAL NEEDLE, 98 CM LENGTH; TROCAR

Model Number	407206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/14/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
An event of a pericardial effusion and subsequent patient death was reported.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.
Event or Problem Description
During a pulmonary vein isolation and atrial fibrillation ablation procedure, the patient decompensated and life saving measures were taken.After two hours of resuscitation, the patient passed away.When drawing blood for act checks after transseptal puncture, blood appeared darker and the patient's vital signs began worsening.An echocardiogram was performed and a pericardial effusion was diagnosed.The effusion was growing rapidly, and a pericardiocentesis was performed twice.It is believed the death was due to the pericardial effusion, however, the cause of death was not confirmed as no autopsy was performed.There is no alleged device malfunction.
Additional Manufacturer Narrative
Based on the information received, the cause of the reported effusion and subsequent death remain unknown.

• Brand Name: BRK TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Common Device Name: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 12598825
• Report Number: 3008452825-2021-00463
• Device Sequence Number: 4200470
• Product Code: DRC
• UDI-Device Identifier: 05414734205122
• UDI-Public: 05414734205122
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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 Expiration Date: 05/31/2024
• Device Model Number: 407206
• Device Catalogue Number: 407206
• Device Lot Number: 8021169
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death