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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One tactisys¿ quartz sn: (b)(6) was received for evaluation.The tactisys was powering on, and a prolonged audible beep was heard.This indicated an unsuccessful power-on-self-test (post) and a failure to established communication.The front enclosure was temporarily removed, and visual inspection revealed the cmos (complementary metal oxide semiconductor) battery was not seated properly in the battery holder.Based on the information and investigation provided to abbott, the root cause was isolated to the cmos battery.The batch record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformance's associated with the reported event were identified.
Event or Problem Description
During a typical atrial flutter procedure, there was a procedural delay due to a tactisys issue while the patient prepared on the table.When prepping for the tactiflex ablation catheter, it was noted that the tactisys quartz was blinking red and would not connect to the ensite x system.Troubleshooting included checking and reseating all the connections, powering the tactisys quartz off and on, confirming that the correct serial number was entered into the system, and opening a new catheter, but the issue persisted.A tactisys was borrowed from another account, which took about 15 minutes.Everything was plugged in again, the tactisys displayed a green light and properly connected to the mapping system.The procedure was then completed with no adverse consequences to the patient.

• 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: 24461864
• Report Number: 2184149-2026-00047
• Device Sequence Number: 9376204
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)8121385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/26/2026

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: PN-004 400
• Device Catalogue Number: PN-004 400
• Device Lot Number: 8121385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown