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

Model Number	H700488
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrioventricular node ablation case, the output of the ampere generator displayed as 0 and troubleshooting caused a delay.Replacing the catheter and the grounding pads did not resolve the issue.The generator was exchanged and the case was completed with no harm to the patient.
Additional 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.Normal wear from use was observed on the exterior chassis.No physical damage was observed the power cord connector.A known good power cable was plugged into the unit and no anomalies were observed.Evaluation testing which includes irrigated/non-irrigated catheter identification, temperature, resistance testing, and timing testing were all successful.The foot switch was also connected with successful results.Review of system log files provided inconclusive data as no anomalies were found for the reported event date.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 provided to abbott and the investigation performed, the reported event was unable to be confirmed.The returned product functioned properly during the evaluation.

• 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: 13392632
• Report Number: 2184149-2022-00030
• Device Sequence Number: 17238845
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Followup
• Report Date (Section B): 03/02/2022

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 Catalogue Number: H700488
• Device Lot Number: 7631896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• 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: 01/18/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown