MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X SOFTWARE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number AFD-ENSITE-SW

Device Problem Application Program Problem (2880)

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

Related manufacturing reference: 3005334138-2023-00041, 3005334138-2023-00042, 3005334138-2023-00043, 3008452825-2023-00048.During a redo atrial fibrillation procedure, communication and display issues occurred as well as an effusion needing pericardiocentesis and the case was cancelled.In the beginning of the case, everything seemed fine.The system passed validation, and everything appeared green on the prs window.After a while, with cs in place and transseptal puncture completed, when tactiflex was connected to the system, an error message appeared indicating inadequate positioning of the impedance patches.Troubleshooting included revalidating, resetting check metal field and metal baseline, recollecting respiration, turning off "irregular respiration detection", rebooting the ampliifer, rebooting the dws.We decided to use new impedance patches for the orange and red connection which were difficult to position in the first place due to patient anatomy.The new patching position looked okay.However, when we logged back into the case, we could not resume last study, the following message appeared: "no active enguide included in the study" or something similar, which prevented us from resuming the previous (existing) study.As a result, we had to create a new study, which means that neither the existing blue patch (left leg) nor the tactiflex could be used as the system recognized that they have already been "used".To overcome that, a new blue patch (left leg) was used as well as a new tactiflex catheter.Everything seemed to work fine this time and validation succeeded.Prs positioning looked green, respiration green, tactisys connection green, tactiflex signals ok on ensite, contact for reading worked fine.However, when the tactiflex catheter was inside the left atrium, the catheter contour would freeze every other second for a prolonged period of time and appear red on the ensite x screen.This is a behavior that has been observed when the catheter moves fast between two locations inside the heart, but this normally occurs for half a second or so and only once or twice during the entire study.In a case today, the catheter would be frozen/red most of the time, only to come back to normal behavior for a couple of seconds and then return to frozen/red state.It was impossible to create model or map, since the catheter would stop acquiring points every time it got red.On top of this it was impossible to navigate while only being able to see the catheter's actual location for a second or two and then freezing.Of course, we tried all troubleshooting steps, reconnecting the catheter, resetting sheath filter, new respiration compensation, new metal baseline, new metal check, all seemed to work fine and prs-a & prs-p indicators were constantly green.The second tactiflex was replaced with a new catheter.Despite several repetitions of the troubleshooting steps described above, the behavior remained the same with the catheter freezing/turning red every other second or so.For some reason, the cs signals, even though visible on the recording system, appeared purple / flat on ensite.We decided to completely disconnect the cs catheter from the ensite amplifier.Now suddenly the tactiflex seemed to work fine.We decided to proceed with collecting model points.We collected a few anatomical points of the la model.However, there was a strange observation on the la model.When the catheter reached the roof of the la, the cf arrow would point towards the floor (opposite direction than one would expect).Note that this has nothing to do with the <5g uncertainty threshold, since the cf was good enough to have the arrow visualized to the correct direction.We then asked the physician to curve the catheter tip towards the red rod on his handle.What happened was that the catheter tip actually deflected towards the blue rod.And vice versa.It seems as if the magnet information was behaving the other way around (as if the two magnets were wrongly placed inside the catheter tip.Due to all the above, the decision was made to switch to carto which caused a delay.

Manufacturer Narrative

Review of the provided study data shows several tactiflex disconnections and re-connections, resulting in the location being unknown.The ensite x notifies the user of an unknown location by turning the catheter red on the screen.The cause for the reported crash / freeze and subsequent delay could not be conclusively determined.

Manufacturer Narrative

Additional information: g3, h2, h3 the study data was provided and reviewed.The first study revealed that throughout the available segment recordings, all waveforms (surface, egm, and navx surface impedance) are saturated and the catheter status indicator (¿gumball¿) tooltip states ¿system impedance error¿.Saturated waveforms can indicate a poor system reference.The dws.Log includes many surface impedance error messages, which aligns with the field¿s event description.According to the event description, replacing the surface patches resolved the impedance error messages.From this, we can conclude that the first issue (system impedance error message) was caused by inadequate surface patch placement or electrical connection.Every segment in the second study with duration greater than 10 secs was reviewed and there was no observed freezing.This reported freezing does not present in review mode.The event description also states that cs catheter waveforms were flat/purple on ensite x, but were visible on the recording system.The cs catheter was disconnected from the amplifier in auto segment 78.Cs waveforms are visible in review mode right before the catheter was disconnected, even though they were reportedly not available in the real time study.It¿s unclear at this time if this observation is related to the reported tactiflex freezing issue.The reported event stated that the tactiflex was freezing in the display.Every segment in the study with duration greater than 10 secs was reviewed and there was no observed freezing.This reported freezing does not present in review mode.No further investigation is possible.Review of the provided study data shows several tactiflex disconnections and re-connections, resulting in the location being unknown.The ensite x notifies the user of an unknown location by turning the catheter red on the screen.The cause for the reported crash / freeze and subsequent delay could not be conclusively determined.

• Brand Name: ENSITE¿ X SOFTWARE
• 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: 16337359
• MDR Text Key: 309181793
• Report Number: 2184149-2023-00034
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K160187
• 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,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFD-ENSITE-SW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• 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
• Treatment: INQUIRY¿EP CATHETERS; TACTIFLEX¿ ABLATION CATHETER, SE X 3