MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X SOFTWARE V3.0.2; Computer, diagnostic, programmable

Model Number	ENSITE-SW-3.0.2
Medical Device Problem Code	Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During catheter set up for ablation of a slow pathway, the se portion of the ablation catheter was not recognized by the ensite amplifier which caused a delay in procedure.The catheter was disconnected and reconnected, the system was restarted, and presets were removed; however, the issue persisted.The catheter was replaced with another tactiflex with a different lot number which did not resolve the issue.A non-abbott (biosense webster celsius) ablation catheter was used to complete the procedure without consequence.The issue was determined to be due to not loading the ensite-tfm-3.0.2 software during the recent software upgrade for pfa visualization.
Additional Manufacturer Narrative
Abbott is unable to evaluate the product involved in this incident based on the information received.The cause of the reported event involving the catheter was not being recognized and subsequent delay could not be conclusively determined.However, it was reported the issue was determined to be due to not loading the ensite-tfm-3.0.2 software during the recent software upgrade for pfa visualization.The product does not have a lot number, therefore the primary di number is provided (d4), but full udi information is not available.

• Brand Name: ENSITE X SOFTWARE V3.0.2
• Common Device Name: Computer, diagnostic, programmable
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19940126
• Report Number: 2184149-2024-00135
• Device Sequence Number: 15311732
• Product Code: DQK
• UDI-Device Identifier: 05415067050014
• UDI-Public: 05415067050014
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K231415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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: ENSITE-SW-3.0.2
• Device Catalogue Number: ENSITE-SW-3.0.2
• 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: 07/18/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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