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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 03/04/2024

Event Type  Death  

Event Description

During the procedure, an effusion occurred and the patient expired.It was reported that while looking at the ultrasound image and assessing anesthesia readings, an x-ray and echocardiogram confirmed a pericardial effusion which was caused by a perforation.A pericardiocentesis was performed with 375 ml of fluid removed from the patient.The patient later underwent open heart surgery and expired.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported effusion and death remains unknown.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: 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: 18977944
• MDR Text Key: 338589192
• Report Number: 3008452825-2024-00169
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female