MAUDE Adverse Event Report: ST. JUDE MEDICAL AMPERE¿ RF ABLATION GENERATOR; EP GENERATOR

Model Number H700489

Device Problem Communication or Transmission Problem (2896)

Patient Problem Heart Block (4444)

Event Date 11/08/2021

Event Type  Injury  

Event Description

During an atrioventricular nodal reentrant tachycardia ablation procedure, an atrioventricular block and subsequent elongation of the pr interval were noted during the last ablation.At the start of the procedure, the ablation parameters were set to 50 watts and 50 degrees celsius.Following the connection of the ablation catheter, the parameters reset to 30 watts and 65 degrees celsius.The parameter change was not noted until after the last ablation.A temperature rise was not noted during the ablations, but upon review, some temperatures were noted to reach 60 degrees celsius.The physician believed the cause of the atrioventricular block and subsequent elongation of the pr interval was due to the higher temperatures.The patient was put under surveillance in the hospital and the physician evaluated if there was a need for a pacemaker or not dependent on the evolution of the patient's heart rate.Since then, the patient was noted to be in a stable condition with improvement of the pr elongation and no intervention needed.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for evaluation.Visual inspection of the returned generator confirmed all connectors, switches, and labels appeared to have no physical damage.All the mounting hardware was secured.The returned generator was powered on, and the unit completed the post (power on self test) successfully and the screen display came up normally.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.Rf energy output was applied during ablation testing and no anomalies were identified throughout investigation as performed.The log files were reviewed on the event date and revealed that the ablation settings were set to 40w and 50c prior to a catheter being connected.The ablation settings should be set after connecting a catheter as once a catheter is connected, the ablation settings will revert to their default values.Per the instructions for use document."initial connection of a catheter resets the settings to the default settings ¿ be sure to set the values after connecting the catheter, or your settings will be replaced." the root cause of the reported event was isolated to the operation instructions in the ifu not being followed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received and the investigation performed, the cause for the reported event was confirmed and isolated to the operation instructions in the ifu not being followed.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for evaluation.Visual inspection found all labeling and input/output connectors to be free of physical damage.The returned generator was powered on, and the unit completed the post (power on self test) successfully and the screen display came up normally.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.Rf energy output was applied during ablation testing and no anomalies were identified during testing.The log files were reviewed on the event date and confirmed that the ablation settings were set to 40w and 50c prior to a catheter being connected.The ablation settings should be set after connecting a catheter as once a catheter is connected, the ablation settings will revert to their default values.Per the instructions for use document, the operation order listed in the basic operation section indicates to connect the catheter and then to configure the ablation settings.The root cause of the reported event was isolated to the operation instructions in the ifu not being followed.Based on the information provided to abbott and the investigation performed, the reported event was confirmed; however, the device functioned normally throughout product testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received and the investigation performed, the cause for the reported event was isolated to the operation instructions in the ifu not being followed.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Type of Device: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12843618
• MDR Text Key: 281008678
• Report Number: 2184149-2021-00368
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700489
• Device Lot Number: 4661128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male