MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X SOFTWARE V3.0; Computer, diagnostic, programmable

Model Number ENSITE-SW-03

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

Review of the ensite x cardiac mapping system voxel mode confirms that in some cases a shift can occur.If a shift occurs, it is recommended to remove any metal that may be causing distortion.Additionally, use the prs setup screen to align the prss to the original location, reset metal baseline, or begin a new study.See ensite x ep system ifu, setup, system, prs sub-tab.The cause of the reported shifts and subsequent cancellation remain unknown.

Event Description

During a redo ablation procedure, multiple catheter position shifts were noted.A major shift occurred during attempt at lateral mitral isthmus line.Attempts to use cs 5 as positional reference did not solve the problem.Ablation would move 10 mm or more from previous locations during rf therapy, resulting in therapy being delivered inaccurately.The right pulmonary veins were successfully isolated.A major shift then occurred when attempting a lateral mitral isthmus line and therapy was aborted.

Manufacturer Narrative

The case study and collect logs were provided for review.The reported event stated that "multiple catheter position shifts were noted" occurred.Review of the movement of the ablation catheter in the impedance data and the magnetic data was compared and showed an impedance shift at multiple points in the segments.However, no software anomalies were found during this investigation.The shifts appears to be due to external factors or stim steering.Potential workarounds are to ensure all patches are properly placed and adhered to patient properly.Ensure that pacing channels are turned off if not actively pacing.

• Brand Name: ENSITE X SOFTWARE V3.0
• Type of Device: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18777875
• MDR Text Key: 336298881
• Report Number: 2184149-2024-00037
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SW-03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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