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	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a repeat pulmonary vein isolation procedure for atrial fibrillation using the tactisys quartz system, the contact force on the tactiflex duo catheter could not be reset and signals displayed on the ensite x system appeared purple.Verification of system connections, system restart, and exchange of two tactiflex duo catheters did not resolve the issue.Subsequent use of a tactiflex se catheter also did not resolve the issue, and the procedure was cancelled.

• 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 ; +1(651)756-5400
• MDR Report Key: 50898569
• Report Number: 2184149-2026-00250
• Device Sequence Number: 20340120
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)7441324
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 7441324
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2020
• 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
• Patient Sex: Unknown