MAUDE Adverse Event Report: ABBOTT 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	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the supraventricular tachycardia and typical atrioventricular nodal reentrant tachycardia procedure, the tachycardia was abandoned due to a recognition issue.The ampere would not connect to the cool point pump.The ampere was power cycled and the cable was replaced with no resolution.The ampere would also no recognize the catheters.The issue could not be resolved and the procedure not completed.There were no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One ampere¿ rf ablation generator was received for evaluation.The product functioned as anticipated during testing with no abnormalities identified that would result in the reported complaint.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: 24188690
• Report Number: 2184149-2026-00024
• Device Sequence Number: 9600247
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: (01)05415067004888(10)5984603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/23/2026

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: 5984603
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2015
• 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 Age: 26 YR
• Patient Sex: Female