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 03/13/2024

Event Type  Injury  

Event Description

During a mitraclip procedure for a patient with grade 4 mixed mitral regurgitation (mr), vessel tortuosity, and a rotated heart, a small pericardial effusion was noted on the echocardiogram.Two mitraclips were implanted and the mr was reduced to grade 1.At the end of the procedure a small pericardial effusion was noted on the echocardiogram.The patient was closely monitored over the next hours.There was no clinically significant delay.Per the physician, the pericardial effusion was caused by the difficult anatomy at the septum and several attempts to achieve transseptal access with the puncture device.There was no device malfunction or allegation against an abbott device.The procedure was successful, and the devices functioned as intended.

Manufacturer Narrative

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.

• 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: 19029858
• MDR Text Key: 339212784
• Report Number: 3008452825-2024-00184
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other