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

Model Number PN-004 400

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, the tactisys did not display catheter contact force.The catheters were replaced three times which did not resolve the issue.One of the catheters was used without contact force to complete the procedure with no consequences to the patient.

Manufacturer Narrative

One tactisys¿ quartz was received for analysis.Visual inspection revealed the input, output connectors and controls appeared to be free of physical damage.All the mounting hardware was secured.Normal wear was observed on the exterior chassis.The quartz was powered on and audible beeps were observed which indicates the quartz successfully booted and communication was established.A known-good catheter was connected, and valid contact force was observed.A fiso diagnostic verified all fiso compact module signals were within specifications.The tactisys quartz was left-on for an extended period and no anomaly was observe; communication and valid contact force were maintained.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 root cause of the reported contact force issue could not be conclusively determined as the returned tactisys functioned as expected throughout investigation.

• Brand Name: TACTISYS¿ QUARTZ ABLATION SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18343765
• MDR Text Key: 331064979
• Report Number: 2184149-2023-00246
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: 07640157990194
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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
• Device Operator: Health Professional
• Device Model Number: PN-004 400
• Device Lot Number: 6973491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1