MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ PRECISION¿ SOFTWARE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number H702496

Device Problem Computer Software Problem (1112)

Patient Problem Cardiac Perforation (2513)

Event Date 12/13/2017

Event Type  Injury  

Event Description

Related manufacturing ref 3005334138-2018-00002, 2182269-2018-00002.Two hours following an endocardial ventricular tachycardia procedure, a tamponade occurred.While mapping the left ventricle, the catheter displaced below the collected anatomy.The catheter would not make contact with the anterior wall on the mapping system although the catheters were in place as confirmed by fluoroscopy.The anatomy and catheters were manually realigned and the procedure was completed.There were periods of hypotension during the procedure however a transoesophageal echocardiogram revealed no perforation.Two hours post procedure, a tamponade was noted and a pericardiocentesis was performed to stabilize the patient.

Manufacturer Narrative

A software evaluation was performed which indicated three total shifts.The first shift occurred approximately 15 minutes after validation and precision displayed the error messages ¿velocity has detected a location shift.Check patches and verify current position of all enguides.If a shift has occurred, use enguide alignment or revalidate.¿ and ¿loose left patch detected¿.At this time there was a disturbance in the patch impedance values consistent with patient movement.The second shift occurred one hour after validation and was seen on the rv catheter.The third shift was seen over a period of two hours on the rv catheter and was consistent with infusion.If a shift is observed, it is recommended to use enguide alignment to return the catheters to their previous positions.Setting the positional reference to an intracardiac electrode provides better drift compensation as specified in the ifu.

• Brand Name: ENSITE¿ PRECISION¿ SOFTWARE
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7169234
• MDR Text Key: 96534073
• Report Number: 2184149-2018-00001
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K160210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H702496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: AGILIS STEERABLE INTRODUCER; LIVEWIRE CATHETER; TACTICATH SENSOR ENABLED CATHETER
• Patient Outcome(s): Required Intervention
• Patient Weight: 90