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

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

Patient Problems Arrhythmia (1721); Hematoma (1884); Perforation (2001); Cardiac Tamponade (2226); Heart Block (4444)

Event Date 01/01/2019

Event Type  Death  

Event Description

It was reported that a journal article was received indicates a retrospective single-center analysis, a total of 199 patients who underwent ventricular tachycardiac catheter ablation on the basis of structural heart disease (shd) or coronary artery disease from january 2019 to october 2020 at the institution were included.Shd is defined as any congenital or acquired cardiac defect affecting the non-coronary components of the heart.Patients with ischemic cardiomyopathy (icm), which is defined as significantly reduced cardiac function resulting from coronary artery disease and non-ischemic cardiomyopathy (nicm) , which includes all conditions of decreased cardiac function not associated with coronary artery disease, were also included.All procedures were performed with three-dimensional electroanatomical mapping system under analgosedation using continuous propofol infusion in addition to morphine derivatives.Catheter ablation was performed using an open-irrigated ablation catheter with or without contact force measurement.A high-density voltage map was acquired using a three-dimensional electro-anatomical mapping system (3deam) combined with a high-density multipolar mapping catheter.Non-boston scientific systems and catheters were used along with boston scientific's rhythmia mapping system, intellanav mifi xp ablation catheters, and intellamap orion mapping catheters.In total, 13 intra- and post-procedural adverse events were reported.Of note, 5 of these complications were minor adverse events without clinical relevance (access site hematoma without relevant blood loss).One patient experienced a cardiogenic shock in a redo-procedure due to vt recurrence and died intra-procedurally (not in the initial procedure).4 patients suffered from high -degree av-block in the initial procedure.1 patient experienced a delayed pericardial tamponade, which had to be treated by pericardiocentesis.And finally, in 2 patients, inadvertent puncture of the pleural space occurred during pericardial puncture without any clinically relevant consequence.During follow-up, a total of 14/199 patients died.Of note, 3/14 patients died of cardiac death (1 patient of sudden cardiac death), 2/14 died of a non-cardiac death and in 9/14 patients the cause of death was unknown.Halbfass, p.,ludwig, d.,sonne, k.,nentwich, k.,ene, e.,berkovitz, a.,foldyna, b.,barth, s.,muller, j.,lehmkuhl, l.,lusebrink, u.,waechter, c.,deneke, t.Acute and long-term outcomes of vt radiofrequency catheter ablation in patients with versus without an intramural septal substrate.Indian pacing electrophysiol j.2022.22:2-9.

Manufacturer Narrative

It was indicated that no devices were returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16732965
• MDR Text Key: 313222445
• Report Number: 2124215-2023-13681
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION CATHETER
• Patient Outcome(s): Death; Required Intervention