MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 1500T11 -CP CARDIAC ABLATION GENERATOR; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 85523

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Excessive Heating (4030)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in a subsequent submission. .

Event Description

During the procedure, the ablation catheter was used for approximately 90 seconds and the distal signal became distorted and unreadable on ensite and the non-abbott recording system.When the distortion occurred, ablation had stopped due to a high impedance error message.The catheter checked and the grounding pad was replaced with no resolution.The catheter was replaced and a new connecting cable was used which resolved the distal signal reading on ensite, but not on the non-abbott recording system.The input pin, egm out cable, and t cable were replaced with no resolution.The procedure was continued with only the egm signals on ensite.Once the generator was restarted and the ablation parameters were set, ablation was not possible with the non-abbott catheter.The generator displayed a high temperature error message and "fl" error for the temperature.The generator was restarted several times, and the connections were verified but ablation was not able to be delivered.The procedure was rescheduled.There were no adverse consequences to the patient due to the cancellation.

Manufacturer Narrative

One 1500t11 -cp cardiac ablation generator was returned for investigation.Ac power was applied to the rf generator which briefly displayed the software version of 3.0 prior to completing a successful power on self-test.Default values were then displayed in numerical format that is consistent with this software version.An ablation trial was performed utilizing a typical ablation configuration under various rf power and filter settings within the application.An increase in rf power proportionately raised the abl distal signal amplitude as anticipated with no noise indicated at the proximal location.All displayed impedance values were found to be within the anticipated range.Note: if the clear/ mode button is depressed while in the ablation state and the cool point pump is connected, a three second delay will count from 3 to 1 on the impedance display and ¿fl¿ will be on the temperature display.The pump flow rate will then change to 2mn/min, and the system will enter the results state.Based on the information provided to abbott and the investigation performed, the root cause of the high temperature and impedance, and noise cannot be conclusively determined as no abnormalities were identified.The returned product operated as designed during the evaluation period.

• Brand Name: 1500T11 -CP CARDIAC ABLATION GENERATOR
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 9652780
• MDR Text Key: 187930621
• Report Number: 2030404-2020-00005
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P060019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other