MAUDE Adverse Event Report: MEDTRONIC CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number DIAMOND TEMP CATHETER

Device Problems Component Missing (2306); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During procedure to treat arterial flutter, a connection box - maestro g2 was selected for use.It was reported that as the catheter was connected with the intellanav maestro box the catheter provided for about one minute raw signals until they disappeared.The catheter was about 5 mins visible in rhythmia until all signals disappeared as well.It was found that the middle pin of the connector was missing and stuck in the box of the diamond temp generator.(the setup is that the clinic uses rhythmla with diamond temp cath.) procedure was completed using non bsc product (osypka generator).No patient complications were reported.Product is expected to be returned.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17489802
• MDR Text Key: 320694447
• Report Number: MW5122320
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: DIAMOND TEMP CATHETER
• Patient Sequence Number: 1