MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE VELOCITY¿ EPT GENCONNECT KIT; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number 100011879

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2018

Event Type  Injury  

Event Description

Related manufacturer report number: 2184149-2018-00158, 9680001-2018-00139, 9680001-2018-00140.During an atrial flutter ablation procedure, there was noise on signals 1 and 2 of the workmate system and those signals didn't display on the ensite system.The impedance value remained at 999 ohms and wouldn't communicate with the tactisys quartz.The catheter was replaced and functioned as intended initially, but after a series of ablations communication was lost.The tactisys was power cycled several times and communication was restored.After three more ablations a steam pop occurred.The catheter was replaced to a non-abbott catheter with a non-abbott generator.Prior to inserting the catheter, the temperature was confirmed to be high.It was replaced again but the issue remained, so the procedure was cancelled.There were no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.The device history record was unable to be reviewed as the lot number was unavailable.

• Brand Name: ENSITE VELOCITY¿ EPT GENCONNECT KIT
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7899409
• MDR Text Key: 121434188
• Report Number: 2184149-2018-00159
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734210546
• UDI-Public: 05414734210546
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160187
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100011879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other