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

Model Number ENSITE-SYSTEM-01

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

Patient Problem Cardiac Perforation (2513)

Event Date 06/17/2021

Event Type  Injury  

Event Description

Related manufacturer report number: 3008452825-2021-00367.During an atrial fibrillation procedure, a pericardial effusion occurred.No location was displayed in the acquisition window during most of the procedure but occasionally, the catheter would locate.The catheter would not collect geometry in certain areas and would not display manually collected points, or auto-mapped points on the map.The cable was unplugged, respiratory gaiting was disabled, and sheath filters were reset with no resolution.Additionally, the automark meter would not display lesion time or impedance drop.The meter was reset, and the automarks were reselected and all connections were assessed, but the issue persisted.While ablating the ridge, the patient became hypotensive and a transesophageal echocardiogram showed a pericardial effusion.A pericardiocentesis was performed to stabilize the patient.It was noted that there was difficulty trouble keeping the sheaths fully engaged across the septum and readjustment was done often.At one point the impedence rose to 300+ ohms when the patient was hypotensive.

Manufacturer Narrative

With the information provided we are unable to determine an exact root cause for the pericardial effusion.There were a few observations that could be related to a cardiac perforation that are unrelated to system performance: large impedance rise during ablation (as noted by the fce), high power rf ablation, and high contact force values throughout the study.Each of these items were observed in the area (lspv/laa ridge) where the effusion was noted by the physician.Based on the investigation performed and the information provided, the cause of the reported event remains unknown.

Manufacturer Narrative

Corrected data: h6 (medical device problem code).

• Brand Name: ENSITE¿ X EP SYSTEM
• 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: 12153512
• MDR Text Key: 261249747
• Report Number: 2184149-2021-00220
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: No
• 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: TACTICATH SE.
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 94 KG