MAUDE Adverse Event Report: ST. JUDE 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	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an accessory pathway procedure, a contact force issue with two tactisys units resulted in a delay to the procedure.After completing the 1.7.2 upgrade on the tactisys (first case after the upgrade), contact force was unable to be obtained on four different tactiflex se catheters and two tactisys units.Initially, the first tactiflex se was connected to the tactisys.Contact force was detected but was out of range and would not reset.Next, a second tactiflex se was connected to tactisys and the same issue occurred.Next, a third tactiflex se was connected to a different tactisys and the same issue occurred.The third tactiflex se was then connected to the original tactisys and the issue persisted.Lastly, a fourth tactiflex se was connected to both tactisys units with no resolution.Cables were checked, connected, and reconnected.The ensite x dws and tactisys units were power cycled, and the amplifier was also restarted twice during troubleshooting.The case was restarted with no resolution.A safire tx was utilized without issue to complete the procedure with no adverse consequences to the patient.Later, both tactisys units were tested with numerous catheters in a non-clinical setting and neither tactisys would detect force.The account has been using a loaner regional demo tactisys unit until their replacement arrived and contact force catheters could be utilized with the demo unit and now with their replacement tactisys unit as well.
Additional Manufacturer Narrative
One tactisys quartz was received for evaluation.Fiso diagnostic revealed a signal loss at channel three and no contact force data was displayed.Based on the information and investigation provided to abbott, the root cause was isolated to debris within the lc/lc fiber optic adapter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the optical issue were identified.

• Brand Name: TACTISYS¿ QUARTZ ABLATION SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE 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: 19554104
• Report Number: 2184149-2024-00105
• Device Sequence Number: 6715933
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: (01)07640157990194(10)7042891
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 7042891
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2019
• 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 ABLATION SYSTEM.
• Patient Sex: Unknown