MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X EP SYSTEM AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-AMP-02

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

During the atrial fibrillation procedure, while inserting the catheter into the body, it was noted that electrodes 1 and 3 were visualized as elongated and out of the heart resulting in a procedure delay.The signals and contact force were displaying appropriately.Troubleshooting of the issue included rebooting the tactisys, reconnecting the catheter, re-doing respiration, revalidating, restarting the study, rebooting the generator, reconnecting the ampere connection and the yellow/green tactisys cable, with no resolution.Three catheters were replaced, and the yellow/green tactisys cable was exchanged, with no resolution.The catheter was replaced a fourth time and a non-abbott cardiolab focus laser was used to complete the procedure with no adverse consequences to the patient.After the procedure was ended, field engineers tested the amplifier ablation ports.Ports 53 and 55 did not pass the tests confirming the amplifier was causing the issue.The amplifier was replaced.

Manufacturer Narrative

One ensite x amplifier was received for evaluation.Visual inspection revealed the front ports, rear ports have some wear consistent with use over time.The external enclosures were showing gaping in multiple locations (front to top, right to bottom, left to bottom, rear to bottom), which was consistent with a scuff mark (top enclosure) where it was impacted physically to the top-front from an angle, and potentially top-rear.Visual internal inspection revealed that the gapping of the right/left to bottom enclosures were only to an offset (due to a single impact).Internal visual inspection also revealed that the top panel guide posts are leaning towards the rear, also consistent with a physical impact to the top towards the rear event.The bottom enclosure has some physical damage to the guide arms, which would be non-visual, and would remain functionally sound.For evaluation purposes the port 3 and port 4 small form-factor pluggable (sfp) were exchanged.The amplifier was powered on and then the amplifier booted to a solid green ¿ready¿ light emitting diode (led) status.This indicated the amplifier passed the power-on-self-test (post) and then successfully communicated with the test station tracker software successfully.The intra-cardiac test was then performed, and it revealed that ablation channels 1 and 3 (channels 53, 55) were non-functional (electrically open), which was further isolated to the front panel.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to the front plane.The communication issue causing the procedure delay was also reported via 2184149-2022-00297 and 2184149-2022-00296 involving the ensite x amplifier and ampere rf.

• Brand Name: ENSITE X EP SYSTEM AMPLIFIER
• 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: 16040297
• MDR Text Key: 306330536
• Report Number: 2184149-2022-00312
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8301236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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
• Patient Sex: Male