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

Model Number	H700488
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation / atrial flutter procedure, optical and impedance issues occurred, and the procedure was cancelled.It was reported that the contact force values would intermittently go in and out.The catheter was replaced which seemed to resolve the issue, but then contact force values appeared incorrect.It was also reported that the impedance value on the ampere generator was displayed as 999.A third catheter was introduced, and the tactiflex rf cable was replaced, but the issue persisted, and the procedure was abandoned.It was unknown as to whether the tactisys or the ampere generator caused the issue.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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.The cause of the reported impedance issues and subsequent cancellation remains unknown.
Additional Manufacturer Narrative
One ampere generator was received for analysis.The product functioned as anticipated during testing with no abnormalities 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.Based on the information provided to abbott and the investigation performed, the cause for the reported impedance issue and subsequent cancellation remains unknown.

• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22078086
• Report Number: 2184149-2025-00100
• Device Sequence Number: 21010331
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: (01)05415067004888(10)7940631
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 07/23/2025

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: 7940631
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/09/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/20/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TACTISYS¿ QUARTZ ABLATION SYSTEM.
• Patient Sex: Unknown