MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTISYS QUARTZ ABLATION SYSTEM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number PN-004 400

Device Problem Communication or Transmission Problem (2896)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer report number: 2184149-2020-00181, 3008452825-2020-00588.During the procedure, the communication between ensite and ampere and tactisys was unstable, and when the catheter was connected, communication with ampere and tactisys was disconnected.When the tactisys was rebooted, communication was sometimes possible and sometimes not, and when the tacticath was connected, communication was stopped again.Since the same phenomenon occurred multiple times, the tactisys was repeatedly rebooted and eventually was able to communicate.However, because the study was stopped for more than 30 minutes, propofol was additionally administered to the patient.The contact force value was about 10 g before the rf delivery, but it increased rapidly to about 30 g immediately after the rf delivery.The procedure was completed without replacing the devices and there were no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be determined.

Manufacturer Narrative

One tactisys¿ quartz was received for evaluation.The returned quartz was powered on and an audible beep was observed to indicate a successful boot.Communication was established.A known-good catheter was connected and valid contact force was observed.The field reported event was not reproducible as the quartz was left-on for an extended period and communication was maintained.He review determined the process was performed and completed in accordance with abbott specifications and procedures.The root cause remains undetermined as the field reported event was not reproducible.

• Brand Name: TACTISYS QUARTZ ABLATION SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10767910
• MDR Text Key: 214100303
• Report Number: 2184149-2020-00180
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2021

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
• Device Model Number: PN-004 400
• Device Lot Number: 5823645
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/01/2020
• Supplement Dates Manufacturer Received: 12/20/2020; 02/02/2021
• Supplement Dates FDA Received: 12/20/2020; 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPERE GENERATOR; TACTICATH SE; AMPERE GENERATOR; TACTICATH SE
• Patient Outcome(s): Other