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	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an av node ablation procedure, the generator displayed a "no catheter connected" message was displayed for both a therapy catheter and a tacticath catheter which caused procedural delays.The generator was replaced with a generator from another facility to resolve the issue.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Add one ampere¿ rf ablation generator sn (b)(6) was received for evaluation at tech center.Visual inspection of the generator revealed all connectors, switches, and labels were free of physical damage.All the mounting hardware were secured.Firmware of the ampere generator was identified as a 1.0.7 us.The generator was powered on, and post (power-on self-test) was successfully completed.The screen displayed ¿no catheter connected" when the catheter simulator was connected properly which duplicated the reported symptom.A known good front panel assembly was temporarily replaced, and functionality was restored.The screen came up normally when the catheter simulator was connected.The original front panel was found to be intermittent as it was re-install, and the symptom could not be reproduced again.One guide pin socket was broken during disassembly.The reported event was confirmed, and the root cause was isolated to the intermittent front panel.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.

• 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: 16610119
• Report Number: 2184149-2023-00067
• Device Sequence Number: 17347716
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/05/2023

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 Catalogue Number: H700488
• Device Lot Number: 8427339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2022
• 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: Female
• Patient Race: White