MAUDE Adverse Event Report: STEREOTAXIS, INC CARDIODRIVE MOTOR; CATHETER REMOTE CONTROL SYSTEM

Model Number 030-005115-8

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

Motor malfunction on cardio drive motor of stereotaxis, in electrophysiology (ep) lab.This created a delay in the case and a different approach to proceed with the procedure was used.Expensive materials were wasted due to the malfunction as well.

• Brand Name: CARDIODRIVE MOTOR
• Type of Device: CATHETER REMOTE CONTROL SYSTEM
• Manufacturer (Section D): STEREOTAXIS, INC; 710 n. tucker blvd., suite 110; saint louis MO 63101
• MDR Report Key: 17029987
• MDR Text Key: 316206751
• Report Number: 17029987
• Device Sequence Number: 1
• Product Code: PJB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 030-005115-8
• Device Catalogue Number: 030-005115-8
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female