MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004PMR9620K20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Complete Heart Block (2627)

Event Date 08/23/2018

Event Type  Injury  

Event Description

Same case as mdr id# 2134265-2018-60914, 2134265-2018-60919, 2134265-2018-60918.It was reported that hypotension, third degree heart block and perforation occurred.During an ablation procedure for left atrial flutter, a polaris x, an intellamap orion, an intellanav mifi oi lrg curve and intellanav mifi oi std curve were selected for use.The physician mapped the left atrium using the orion mapping catheter while pacing from the coronary sinus (cs) catheter.He removed the orion from the left atrium and replaced it with an intellanav mifi oi lrg curve catheter.After coming on ablation for 3 seconds, the generator gave a d07 excessive temperature error.He changed ablation cables and inspected the catheter tip for evidence of char and did not see any.The real time temperature reading on the ablation generator was giving an internal temperature of 86 degrees.The physician did not reinsert the catheter into the body and replaced it with an intellanav mifi oi std curve ablation catheter and began to ablate.They were able to deliver radiofrequency (rf) without any errors and ablated.They did not notice any abnormal readings in regard to temperature, power and impedance.They ablated for roughly 2 minutes when the patient's blood pressure began to rapidly drop and the patient went into third degree heart block.Transesophageal echocardiography (tee) demonstrated a perforation and compressions were started.The procedure was stopped and resuscitation efforts were continued.The patient was then stable and was admitted to the hospital with the possibility of cardiothoracic (ct) surgery depending on how next few hours went.

Event Description

Same case as mdr id# 2134265-2018-60914, 2134265-2018-60918, 2134265-2018-60919.It was reported that hypotension, third degree heart block and perforation occurred.During an ablation procedure for left atrial flutter, a polaris x, an intellamap orion, an intellanav mifi oi lrg curve and intellanav mifi oi std curve were selected for use.The physician mapped the left atrium using the orion mapping catheter while pacing from the coronary sinus (cs) catheter.He removed the orion from the left atrium and replaced it with an intellanav mifi oi lrg curve catheter.After coming on ablation for 3 seconds, the generator gave a d07 excessive temperature error.He changed ablation cables and inspected the catheter tip for evidence of char and did not see any.The real time temperature reading on the ablation generator was giving an internal temperature of 86 degrees.The physician did not reinsert the catheter into the body and replaced it with an intellanav mifi oi std curve ablation catheter and began to ablate.They were able to deliver radiofrequency (rf) without any errors and ablated.They did not notice any abnormal readings in regard to temperature, power and impedance.They ablated for roughly 2 minutes when the patient's blood pressure began to rapidly drop and the patient went into third degree heart block.Transesophageal echocardiography (tee) demonstrated a perforation and compressions were started.The procedure was stopped and resuscitation efforts were continued.The patient was then stable and was admitted to the hospital with the possibility of cardiothoracic (ct) surgery depending on how next few hours went.The device was returned for analysis.Visual inspection revealed dried saline inside the luer and in the irrigation ports of the tip.Dried body fluid was present on the handle and proximal and distal shafts.There was a kink located approximately 2cm from the distal tip proximal to ring 3.Continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box.All electrode/thermocouple resistances measured in spec and were typical.The measurements were repeated in the right and left curve configuration and again, all measurements were within specifications and typical.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The ablation was verified by using the maestro generator 4000 and the metriq pump and the device was found within specifications.X-ray showed a couple of twists in the thermocouple wires, one in the handle and one in the proximal shaft approximately 94.5cm from the tip.The center support was bent.The handle was opened.Multiple twists in thermocouple wire were visually confirmed.The device was connected to the metriq pump that was programmed to 0ml/minute (ablation flow rate) and the pump was left running for 2 minutes.No leakage was seen inside the handle.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 7885068
• MDR Text Key: 120554930
• Report Number: 2134265-2018-60917
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (y/n): N
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: M004PMR9620K20
• Device Catalogue Number: 87047
• Device Lot Number: 0022242109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Date Manufacturer Received: 01/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR