MAUDE Adverse Event Report: ABBOTT MEDICAL TACTISYS¿ QUARTZ ABLATION SYSTEM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	PN-004 400
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction procedure, there were issues with noise on the ecg resulting in cancellation of the procedure.Mapping and ablation were performed, but consolidation was needed.The patient had been sedated during ablation as they were experiencing pain.The prs-ps moved so mapping was performed again.At this time, there was a lot of noise on the ecg.The noise was not able to be resolved, and it was decided to end the procedure due to not being able to map and pace the premature ventricular contraction.It is unknown what was causing the issue.Upon clean up the noise on the ecg disappeared when removing the tactiflex cable from the tactisys.The cable was reconnected, bringing back the noise, and then disconnected and the noise resolved once again.It is unknown what was causing this as the tactiflex was used for mapping at the beginning of the procedure without issue.
Additional Manufacturer Narrative
Additional information: b5, g3, h2.
Event or Problem Description
During a premature ventricular contraction procedure, there were issues with noise on the ecg resulting in cancellation of the procedure.Mapping and ablation were performed, but consolidation was needed.The patient had been sedated during ablation as they were experiencing pain.The prs-ps moved so mapping was performed again.At this time, there was a lot of noise on the ecg.The noise was not able to be resolved, and it was decided to end the procedure due to not being able to map and pace the premature ventricular contraction.It is unknown what was causing the issue.Upon clean up the noise on the ecg disappeared when removing the tactiflex cable from the tactisys.The cable was reconnected, bringing back the noise, and then disconnected and the noise resolved once again.It is unknown what was causing this as the tactiflex was used for mapping at the beginning of the procedure without issue.The tactisys and tactiflex to tactisys cable have both been used in procedures since without issue.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.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.

• Brand Name: TACTISYS¿ QUARTZ ABLATION SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 23042718
• Report Number: 2184149-2025-00151
• Device Sequence Number: 18662541
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)7585440
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P130026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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: PN-004 400
• Device Catalogue Number: PN-004 400
• Device Lot Number: 7585440
• Was Device Available for Evaluation?: No
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 11/18/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/22/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TACTISYS QUARTZ RF CABLE TACTIFLEX SE
• Patient Sex: Unknown