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 Hematoma (1884); Hemorrhage/Bleeding (1888); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a puncture, pericardial effusion and hematoma occurred.The patient presented with idiopathic premature ventricular complexes with inferior axis, right bundle morphology localized to the left ventricular summit.Four venous access sites were obtained in the left and right femoral vein.Two non-boston scientific (bsc) sheaths, a non-bsc intracardiac ice catheter, and quadripolar his catheter were placed into the right atrium.A non-bsc diagnostic catheter was placed through one of the sheaths and placed into the distal coronary sinus at the site of the great cardiac vein/anterior interventricular vein junction.The patient was anticoagulated with heparin to an activated clotting time (act) greater than 300 seconds.A transeptal procedure was completed using the sheath and non-bsc needle.An intellamap orion mapping catheter was introduced through the sheath into the left ventricle to map the left ventricle.Following mapping of the left ventricle, the intellamap orion catheter was exchanged for an intellanav mifi oi catheter and ablation was performed at 50w with a irrigation rate of 30cc/min at the left ventricle outflow region inferior to the left coronary cusp.This immediately affected the premature ventricular contractions (pvc) exit site, shifting it towards the epicardium.The intellanav mifi oi catheter was withdrawn.The coronary sinus catheter was repositioned to a more distal location within the great cardiac vein confirming that the pvc was exiting epicardially.The coronary sinus catheter was then exchanged for the intellanav mifi oi catheter which was advanced to the great cardiac vein/anterior interventricular vein junction and ablation was performed at 15-20w at an irrigation flow rate of 17cc/min.This suppressed the pvc.Additional ablations were made to consolidate the lesion.At this time a moderate pericardial effusion was noted on the intracardiac ice catheter.No ablation parameters appeared abnormal during the procedure, no were any significant changes in impedance noted from the ablation catheter.All catheters were removed from the body, the patient was given protamine to reverse anticoagulation, and a pericardiocentesis procedure was performed and a pigtail catheter was placed in the pericardium.A total of 2400ccs of venous blood was removed from the pericardial space.The patient was transferred to the operating room for an emergent median sternotomy to control the bleeding.The pigtail catheter was removed.A small perforation was noted on the right ventricle, assumed to be caused during the pericardiocentesis procedure.A significant hematoma was noted at the left sided atrioventricular groove, but not site of bleeding could be identified.The patient remained hemodynamically stable throughout the procedure, the sternotomy was closed, and the patient and was taken to the cardiovascular intensive care unit (cvicu).The following day the patient was conscious and doing well.It was not able to be confirmed that the perforation was caused by any particular device, however, it is highly probable that it was caused by either the non-bsc sheath, the non-bsc diagnostic catheter or the intellanav mifi oi ablation catheter.

Manufacturer Narrative

Patient code 1888 hemorrhage added.

Event Description

It was reported that a puncture, pericardial effusion and hematoma occurred.The patient presented with idiopathic premature ventricular complexes with inferior axis, right bundle morphology localized to the left ventricular summit.Four venous access sites were obtained in the left and right femoral vein.Two non-boston scientific (bsc) sheaths, a non-bsc intracardiac ice catheter, and quadripolar his catheter were placed into the right atrium.A non-bsc diagnostic catheter was placed through one of the sheaths and placed into the distal coronary sinus at the site of the great cardiac vein/anterior interventricular vein junction.The patient was anticogulated with heparin to an activated clotting time (act) greater than 300 seconds.A transeptal procedure was completed using the sheath and non-bsc needle.An intellamap orion mapping catheter was introduced through the sheath into the left ventricle to map the left ventricle.Following mapping of the left ventricle, the intellamap orion catheter was exchanged for an intellanav mifi oi catheter and ablation was performed at 50w with a irrigation rate of 30cc/min at the left ventricle outflow region inferior to the left coronary cusp.This immediately affected the premature ventricular contractions (pvc) exit site, shifting it towards the epicardium.The intellanav mifi oi catheter was withdrawn.The coronary sinus catheter was repositioned to a more distal location within the great cardiac vein confirming that the pvc was exiting epicardially.The coronary sinus catheter was then exchanged for the intellanav mifi oi catheter which was advanced to the great cardiac vein/anterior interventricular vein junction and ablation was performed at 15-20w at an irrigation flow rate of 17cc/min.This suppressed the pvc.Additional ablations were made to consolidate the lesion.At this time a moderate pericardial effusion was noted on the intracardiac ice catheter.No ablation parameters appeared abnormal during the procedure, no were any significant changes in impedance noted from the ablation catheter.All catheters were removed from the body, the patient was given protamine to reverse anticoagulation, and a pericardiocentesis procedure was performed and a pigtail catheter was placed in the pericardium.A total of 2400ccs of venous blood was removed from the pericardial space.The patient was transferred to the operating room for an emergent median sternotomy to control the bleeding.The pigtail catheter was removed.A small perforation was noted on the right ventricle, assumed to be caused during the pericardiocentesis procedure.A significant hematoma was noted at the left sided atrioventricular groove, but not site of bleeding could be identified.The patient remained hemodynamically stable throughout the procedure, the sternotomy was closed, and the patient and was taken to the cardiovascular intensive care unit (cvicu).The following day the patient was conscious and doing well.It was not able to be confirmed that the perforation was caused by any particular device, however, it is highly probable that it was caused by either the non-bsc sheath, the non-bsc diagnostic catheter or the intellanav mifi oi ablation catheter.

• 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: 8395281
• MDR Text Key: 137980484
• Report Number: 2134265-2019-02112
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0022926082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Date Manufacturer Received: 03/25/2019
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION CATHETER; INTELLAMAP ORION CATHETER; INTELLAMAP ORION CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR