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

Model Number 87047

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 09/27/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced a pericardial effusion.During an ablation procedure for supraventricular tachycardia (svt) with an intellanav mifi open-irrigated catheter and an intellamap orion catheter, the physician had transseptal access and was burning a left sided pathway.He was on his 3rd or 4th lesion, when anesthesiologist noted patient's blood pressure (bp) was 50 systolic.Intracardiac echocardiogram (ice) showed a large pericardial effusion.The physician removed the ablation catheter and ordered protamine, which was given.Physician performed a pericardiocentesis/thoracentesis and removed 330cc of blood from the pericardium.They waited 15-20 minutes after removal of the pericardial blood and there was no re-accumulation.As the blood was being aspirated, the patient's hypotension improved and they remained normotensive and hemodynamically stable until taken to recovery.They left the surgery with a pericardial drain.The drain was removed the next day and the patient was discharged home.It was believed that the ablation catheter caused the adverse events as hypotension and tamponade occurred after the ablation catheter was in for a while and they had already burned some.It was reported that a coronary sinus catheter, right ventricle catheter, an intracardiac echocardiography catheter and an ablation catheter were all in the body.

Manufacturer Narrative

The device was returned for analysis.Visual inspection showed dried body fluid on the handle, main shaft and distal end.Dried saline was found on the distal end and inside several irrigation ports.The tip motion was evaluated against a curve template.The right and left curves reached the specified areas on the template.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.While manipulating the shaft, continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermocouple resistances measured in spec and were typical.Lcr test was performed and the magnetic sensor met specifications.The device went through multiple ablation cycles.No temperature, tracking, recognition, or communication issues were observed.The device passed inspection and all electrical testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that the patient experienced a pericardial effusion.During an ablation procedure for supraventricular tachycardia (svt) with an intellanav mifi open-irrigated catheter and an intellamap orion catheter, the physician had transseptal access and was burning a left sided pathway.He was on his 3rd or 4th lesion, when anesthesiologist noted patient's blood pressure (bp) was 50 systolic.Intracardiac echocardiogram (ice) showed a large pericardial effusion.The physician removed the ablation catheter and ordered protamine, which was given.Physician performed a pericardiocentesis/thoracentesis and removed 330cc of blood from the pericardium.They waited 15-20 minutes after removal of the pericardial blood and there was no re-accumulation.As the blood was being aspirated, the patient's hypotension improved and they remained normotensive and hemodynamically stable until taken to recovery.They left the surgery with a pericardial drain.The drain was removed the next day and the patient was discharged home.It was believed that the ablation catheter caused the adverse events as hypotension and tamponade occurred after the ablation catheter was in for a while and they had already burned some.It was reported that a coronary sinus catheter, right ventricle catheter, an intracardiac echocardiography catheter and an ablation catheter were all in the body.

• 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: 9232996
• MDR Text Key: 163942910
• Report Number: 2134265-2019-12930
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0023659884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Date Manufacturer Received: 12/04/2019
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION CATHETER; INTELLAMAP ORION CATHETER
• Patient Outcome(s): Required Intervention