MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED 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); Cardiac Tamponade (2226)

Event Date 08/01/2020

Event Type  Injury  

Event Description

Per literature review, it was reported that a study was to investigate the utility of mapping the atrium and ventricle simultaneously with a high density 3d mapping system for ablation of accessory pathways (ap) with the rhythmia mapping system with the intellamap orion catheter from july 2015 to august 2020, 128 consecutive patients underwent an initial procedure of catheter ablation (ca) for an ap guided by a 3d mapping system.All ablation procedures were performed under deep sedation using propofol, dexmedetomidine, and pentazocine.The pentazocine.A dual chamber map was created using the rhythmia system and orion catheter.The potential reference for the 3d map was obtained from two different sites in the coronary sinus, and the maps were obtained from the orion catheter.The rhythmia system has a specific the maps were obtained from the orion catheter.Ablation was performed at the earliest activation site on the av annulus while considering the local potential under pacing from the right atrium or right ventricle.Considering the local potential under pacing from the right atrium or right ventricle.Ablation was performed using irrigation and non--irrigation catheters including blazer, intella nav mifi oi.Cardiac tamponade requiring pericardiocentesis was observed in one patient during the rv catheter insertion.An arrhythmia recurrence was observed in two patients in the single chamber map group and in one in the dual chamber map group and in one in the dual chamber map group.Mori, h., kawano, d., sumitomo, n., muraji, s., nabeshima, t., tsutsui, k.,.Matsumoto, k.(2021).Ultra-high density atrio-ventricular dual chamber mapping as a next generation tool for ablation of accessory pathways.Journal of cardiovascular electrophysiology, 32(7), 1877-1883.Doi:10.1111/jce.15070.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED 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.; 302 parkway, global park; la aurora, heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14632105
• MDR Text Key: 293545006
• Report Number: 2134265-2022-06555
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BLAZER II XP; INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Patient Outcome(s): Other