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 01/26/2024

Event Type  Injury  

Event Description

During a brocken-brough procedure, a cardiac effusion occurred requiring a pericardiocentesis.When connecting a non-abbott (soundstar eco) catheter, error 6150 occurred.It was suggested to exchange the catheter, but brocken-brough was performed first because the images were visible.After the brocken-brough was completed, the patient became hypotensive, and an echocardiogram revealed an effusion, so drainage was performed.The patient stabilized and was returned to the recovery room.The procedure was discontinued, so no action was taken to resolve the error with the non-abbott (soundstar eco) catheter.The physician alleges that when the non-abbott (beeat) catheter was inserted through the neck, it pierced the right ventricle, but this was not confirmed.

Manufacturer Narrative

Additional information: g3, h2, h3 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 cardiac perforation remains unknown.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: 19103205
• MDR Text Key: 340101737
• Report Number: 3008452825-2024-00211
• 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: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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: 03/22/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• 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): Required Intervention