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

Model Number H702496

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer ref: (b)(4).During a left atrial flutter ablation procedure, a noise issue on the catheter and also a shift, mapping, and catheter issues were experienced resulting in a clinically significant delay.During ablation in the left superior pulmonary vein, no issues were noted, however when moving to the anterior of the ridge, all four of the catheters started to shift while radiofrequency was delivered.Multiple trouble shooting steps were taken to resolve the issues during the procedure resulting in the delay.Despite the issues, the procedure was still completed and there were no adverse consequences to the patient.

Manufacturer Narrative

The study data was provided and reviewed.It was reported that " the geometry doubled over itself", ¿all four of the catheters started to shift¿, and "a purple jump glitch was also noted"¿ occurred.Review of the ensite cardiac mapping system reveals behavior that is consistent with a software issue that is addressed by resuming the study.

• Brand Name: ENSITE PRECISION SOFTWARE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11174237
• MDR Text Key: 226997356
• Report Number: 2184149-2020-00243
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K183128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H702496
• Device Catalogue Number: H702496
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD GRID CATHETER
• Patient Outcome(s): Other