MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AMPERE¿ RF ABLATION GENERATOR; Cardiac ablation percutaneous catheter

Model Number	H700488
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrioventricular node ablation procedure, output issues requiring troubleshooting measures resulted in a procedural delay.The generator and catheter were replaced and the procedure was completed with no adverse consequences to the patient.The ablation catheter was inserted into the patient but an error message on the ampere generator read "generator malfunction" and then read "catheter not connected".The cable was replaced twice, and the catheter was exchanged.The ampere was rebooted, but the error message remained.After troubleshooting, it was determined that the issue was with the ampere.The procedure was completed using a non-abbott (biosense webster) generator and catheter.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One ampere¿ rf ablation generator mn h700488 and sn (b)(6) was received for evaluation.Based on the information provided to abbott and the investigation performed, the reported event was unable to be confirmed.The reported product experience observed in the field could not be reproduced in the lab.A review of the engineering logs revealed an ¿ablation control thermalboard power on self test failed¿ errors that corresponded to the reported product experience.The returned product functioned properly during the evaluation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Common Device Name: Cardiac ablation percutaneous catheter
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17941614
• Report Number: 2184149-2023-00207
• Device Sequence Number: 19576038
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H700488
• Device Lot Number: 5012510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown