MAUDE Adverse Event Report: ST. JUDE MEDICAL AMPERE RF ABLATION GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number H700488

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: 2184149-2020-00180, 3008452825-2020-00588.During 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.Log files were returned, however the reported event could not be confirmed.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 ampere¿ rf ablation generator sn (b)(6) pn h700488 was received into the lab for analysis.When power was applied to the generator, normal boot up sequence was observed & all touch pad controls functioned normally with no error messages displayed.All connector ports were tested for functionality, numerous catheter codes were manually applied, various impedance & temperature values were also applied for investigation upon which all values were accurately tracked on the generator¿s display screen.Review of system log files provided inconclusive data as no anomalies were found for the reported event date.He 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 provided to abbott and the investigation performed, root cause of the field reported event could not be conclusively determined as the returned generator functioned as anticipated throughout investigation.

• Brand Name: AMPERE RF ABLATION GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10767894
• MDR Text Key: 214106072
• Report Number: 2184149-2020-00181
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• 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

• Date FDA Received: 11/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700488
• Device Catalogue Number: H700488
• Device Lot Number: 5686525
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TACTICATH SE; TACTISYS QUART; TACTICATH SE; TACTISYS QUART
• Patient Outcome(s): Other