MAUDE Adverse Event Report: ST. JUDE MEDICA TRANSSEPTAL NEEDLE, BRK SERIES; TROCAR

Lot Number	8650985
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a ventricular tachycardia procedure, a cardiac tamponade occurred which required pericardiocentesis.During right ventricle mapping, patient rhythm changed to ventricular tachycardia and an electrical shock was delivered.The system then stated that the posterior patient reference sensor position had changed.The catheters were visualized; however, a new map could not be recorded.The patient references sensors could not be moved back to their original position, so the "set" button was utilized which required re-mapping.The transseptal puncture was re-done and the left ventricle was remapped, and the procedure was successfully completed.During the night, an echocardiogram revealed a cardiac tamponade for which a pericardiocentesis was performed to stabilize the patient.The physician alleged that the second transseptal puncture caused the pericardial effusion.
Event or Problem Description
During a ventricular tachycardia procedure, a cardiac tamponade occurred which required pericardiocentesis.During right ventricle mapping, patient rhythm changed to ventricular tachycardia and an electrical shock was delivered.The system then stated that the posterior patient reference sensor position had changed.The catheters were visualized; however, a new map could not be recorded.The patient references sensors could not be moved back to their original position, so the "set" button was utilized which required re-mapping.The transseptal puncture was re-done and the left ventricle was remapped, and the procedure was successfully completed.During the night, an echocardiogram revealed a cardiac tamponade for which a pericardiocentesis was performed to stabilize the patient.The physician alleged that the second transseptal puncture caused the pericardial effusion.There were no alleged issues with the tacticath se ablation catheter.
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 perforation is a known risk during the use of this device.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Common Device Name: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICA; 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: 17239175
• Report Number: 3008452825-2023-00286
• Device Sequence Number: 7207127
• Product Code: DRC
• UDI-Device Identifier: 05414734205122
• UDI-Public: 05414734205122
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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 Lot Number: 8650985
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 57 YR
• Patient Sex: Male