MAUDE Adverse Event Report: ST. JUDE MEDICAL 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	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ampere¿ rf ablation generator was received for evaluation.The returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported event were identified.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.
Event or Problem Description
During a procedure, there was a communication issue with the ampere generator, resulting in cancellation of the procedure.When the sapphire catheter was connected, the ampere generator showed "catheter not connected" and there were no signals or geometry on the ensite precision system.Two different catheters, and three different catheter connection cables were tried.The fiber to ensite precision display workstation was checked, but the issue persisted.The ampere generator was connected to the ensite precision system.There was not a backup ampere generator at the site, so the procedure was cancelled.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Common Device Name: Cardiac ablation percutaneous catheter
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19645643
• Report Number: 2184149-2024-00116
• Device Sequence Number: 6578761
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: (01)05415067004888(10)7832033
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/01/2024

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: 7832033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• 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: 06/14/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2018
• 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