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

Device Problems Insufficient Cooling (1130); Overheating of Device (1437); Optical Problem (3001)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

During a pulmonary vein isolation procedure for atrial fibrillation and atrial flutter, contact force could not be established resulting in a delay.Four different catheters and a demo tactisys was tried, but the issue did not resolve.A no contact force error message was continually encountered.The procedure was successfully completed with no contact force no adverse patient consequences.After further troubleshooting it was confirmed that the issue was due to the original tactisys in use overheating.There were no alleged issues with the catheters used during the procedure.

Manufacturer Narrative

Additional information: d9, g3, h2, h3 one tactisys quartz, pnwas 400 received into the lab for analysis.Product testing found that contact force values were not available.Contact force values were seen after temporary replacement of an internal fiberoptic cable.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 received and the investigation performed, the cause for the reported event was isolated to an internal fiberoptic cable.

• Brand Name: TACTISYS¿ QUARTZ ABLATION SYSTEM
• Type of Device: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15650919
• MDR Text Key: 305606724
• Report Number: 2184149-2022-00245
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 07640157990194
• UDI-Public: 07640157990194
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• 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 Catalogue Number: PN-004400
• Device Lot Number: 7562402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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