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

Model Number H702496

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complete Heart Block (2627)

Event Date 02/20/2018

Event Type  Injury  

Event Description

During a left sided pulmonary vein isolation (pvi) procedure, the patient woke up and a catheter shift occurred.The shift occurred after isolating the pulmonary veins and while moving the catheter toward the tachycardia located in the his.Ablation was performed inadvertently on the his for 26 seconds, resulting in an atrioventricular (av) block.A temporary pacemaker was implanted until a permanent pacemaker can be placed.The patient remained in stable condition.There was no allegation of a malfunction as the patient was not properly sedated.

Manufacturer Narrative

The reported catheter shift was confirmed.The cause for the shifts are consistent with patient moving during the procedure.Per the ifu, it is recommended to use enguide alignment to return the catheters to their previous positioning.If enguide alignment cannot return the catheters to their previous position, it is recommended to recreate the model.

• 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: 7331420
• MDR Text Key: 102122981
• Report Number: 2184149-2018-00038
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 04/04/2018

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
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/27/2018
• Supplement Dates FDA Received: 04/04/2018
• 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
• Treatment: CELSIUS RMT THERMOCOOL CATHETER
• Patient Outcome(s): Required Intervention