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

Model Number AFD-ENSITE-SW

Device Problems Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Application Program Problem (2880)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

Related manufacturing ref: 3008452825-2022-00716 and 3008452825-2022-00717.During a supraventricular tachycardia procedure, there were communication and temperature issues with two flexability catheters, and performance issues with the ensite x system, resulting in a delay of procedure.At first navx was being used, however the patient had a fat from the crista terminalis.Therefore, the mode was switched to voxel.The flexability se being used was switched to a tactiflex due to technical issues and used for mapping in voxel mode, while using the supreme and cs catheter for mapping in navx mode.The following issues occurred with the ensite x system: there were issues with field scaling in navx mode.Navx field scaling and se field scaling were attempted, but neither worked correctly.A lot of points were deleted, which might have been related to point collection in the sheath; it was desired to use the flexability se catheter for mapping in navx mode, when it was noticed that the patient had a fat.The flexability se catheter never became a green icon and showed poor sensor quality.The cable was replaced, which did not help.The flexability se catheter was then changed to a new flexability se catheter, where the icon turned green and sensor quality was good; the second flexability se gave a continuous temperature alarm, when ablation was started in voxel mode.The flexability se catheter was then exchanged for a tactiflex se, which worked well; in navx mode our hd grid showed poor sensor quality.Changing the cable and field frame did not resolve the issue.All patent reference sensors were green; the prsa was checked and was in the recommend low sternal position.It was moved to a higher plane sternal position before starting a voxel procedure and then the hd grid showed a green icon; the hd grid was in low confidence and collecting false space; there was respiration related catheter movement, causing false space.Using "end expiratory triggering" helped, but did not solve the issue completely; editing the model and collecting a complex map needed manual editing, which takes time and is often not possible in a complex procedure under conscious sedation; respiration compensation did not work as needed in such a patient with continuous changing breathing pattern.The system was collecting false space, related to the positional influence of the respiration pattern on catheter localization; and it took time to switch from navx to voxel mode.The procedure was successfully completed with no adverse consequences.

Manufacturer Narrative

The case study was provided, however collect logs were not.The reported event stated that "there were issues with field scaling in navx mode" occurred.Abbott is unable to evaluate the product involved in this incident based on the information received.The cause of the reported incident could not be determined.The reported event stated that "the hd grid was in low confidence".Collecting more voxels when entering a new area, such as a vein, will help increase the validity of the catheter.The catheter visualization changes depending on the density of voxels surrounding each catheter.When the density of voxels is low, the catheter will show in a low confidence state.When the density of voxels is high, the catheter will show in a high confidence state.See ensite ep ifu, sensor enabled¿ catheter visualization.The reported event stated that false space occurred.Review of the ensite x cardiac mapping system verifies that in some cases a model bloat/false space can occur.The reported event stated that ¿respiration related catheter movement¿ occurred.Abbott suggests monitoring the respiration waveform, if the waveform looks regular recollect the respiration compensation baseline.If the breathing pattern is shallow, then consider turning off respiration compensation, see ensite x ep system ifu, respcomp x.If catheter movement occurs, it is recommended to use conventional ep techniques, such as fluoroscopy or inspection of intracardiac electrogram signals, to confirm catheter location, see ensite x ep system ifu layout, warnings.

• Brand Name: ENSITE¿ X SOFTWARE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 15925609
• MDR Text Key: 305607617
• Report Number: 2184149-2022-00287
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K202066
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• 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: 12/28/2022
• 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: FLEXABILITY¿ ABLATION CATHETER SE; FLEXABILITY¿ ABLATION CATHETER SE