MAUDE Adverse Event Report: ABBOTT MEDICAL AMPERE¿ RF ABLATION GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	H700488
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, there was an impedance issue with the generator resulting in a delay.When attempting to deliver rf energy with the ablation catheter, the impendence would jump from mid 80¿s to greater than 250ohms and could not deliver therapy.The impendence pads were repositioned and then replaced, and the catheter was exchanged with no resolve.The generator was then exchanged which allowed for rf energy to be delivered.The procedure was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One ampere¿ rf ablation generator was received for evaluation.A visual inspection of the returned generator confirmed that all connectors, switches, and labels were intact and showed no signs of physical damage.All mounting hardware was secure, and the exterior chassis exhibited normal wear consistent with routine use.The unit powered on normally, completed the power-on self test (post), and no anomalies were observed.The generator was tested on an ampere test bed system to check the unit¿s functionality.Evaluation testing included catheter identification for both irrigated and non-irrigated types, temperature and resistance simulations, and timing functionality checks.All tests were completed successfully, with the generator accurately tracking and displaying all simulated values.A known-good remote was connected and verified to function correctly, and the foot switch was also tested with successful results.No log files were available for review corresponding to the reported event date.Based on the information provided to abbott and the investigation performed, root cause of the field reported event could not be conclusively determined as the returned ampere generator functioned as anticipated, with no anomalies identified that would result in the reported complaint.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): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT 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: 22702401
• Report Number: 2184149-2025-00138
• Device Sequence Number: 18429301
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: (01)05415067004888(10)5781702
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/12/2025

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: 5781702
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2015
• 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