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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the procedure, when the rf energy was delivered, an alert for the footswitch connection was displayed and the rf delivery was stopped.Immediately after that, it started to irrigate at high flow and rf delivery was started and then stopped itself.The issue was repetitively noted.When the footswitch was disconnected from and then connected to the ampere generator once, the footswitch connection icon was not lit.The ampere generator was power cycled with no resolution.The procedure was continued without using the footswitch until the replacement device arrived.Then, when the footswitch was replaced, the reported issue was not resolved.The issue was resolved by replacing the ampere generator.The originally used footswitch was also connected to the ampere generator, and it could be used normally.There was a clinically significant delay to the procedure due to device replacement.Additional anesthesia was induced to the patient due to the delay.The procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since 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 ampere¿ rf ablation generator was received into the lab for analysis.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 measured during ablation testing and no anomalies were identified throughout investigation as rf output was correctly displayed and measured over an extensive test period.A known good footswitch was connected to the unit and the footswitch connection light was not detected/illuminated.The power supply was temporarily replaced with a known good power supply.Connected the footswitch and footswitch connection light was detected/illuminated and rf energy output was measured during ablation testing and the unit functioned as intended.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, root cause of the field reported event was successfully isolated to abnormal functionality of the power supply board.

• 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: 11186654
• MDR Text Key: 227543252
• Report Number: 2184149-2021-00003
• 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: 03/10/2021

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: H700488
• Device Catalogue Number: H700488
• Device Lot Number: 5052004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 02/22/2021; 03/09/2021
• Supplement Dates FDA Received: 02/23/2021; 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 75