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

Model Number H702496

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  Injury  

Event Description

During the procedure, a shift on the left pulmonary veins occurred after approximately one hour.Everything appeared as expected after creating the geometry of the left atrium and the right veins were isolated.After the catheter was moved to the left side veins, the catheter appeared to be approximately 1cm outside of both veins, which was inaccurate.A new geometry was obtained and the procedure was completed.The procedure was extended by 30 minutes due to this issue.

Manufacturer Narrative

The review of the electronic files confirmed that catheter display shift occurred during the clinical case; the event was verified.The system continues to remain in use at the account.The following are potential reasons why a catheter shift may occur clinically( this list is not inclusive): patient repositioning such as upper limb motion and displacement of the chest or abdomen.Positional reference patch dislodgement.Non-transient shifts can be related to the gravitational shift of body weight as the patient relaxes during the procedure and subsequent gradual impedance changes in the body.Patch connection, adhesion, or placement issues.Powering up or shutting down other lab equipment can cause electro-magnetic interference with the abbott equipment.In addition, changing connections to other lab equipment such as a stimulator or generator can cause catheter shift.

• 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: 7139385
• MDR Text Key: 95531770
• Report Number: 2184149-2017-00082
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/12/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other
• Patient Weight: 82