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 Fistula (1862); Hematoma (1884); Pericardial Effusion (3271); Pericarditis (4448)

Event Date 06/23/2020

Event Type  Injury  

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.

Event Description

Segreti l;de simone a;schillaci v;bongiorni mg;pelargonio g;pandozi c;di cori a;stabile g;pepe m;zucchelli g;shopova g;de lucia r;ferrari c;casati f;malacrida m;solimene f.A novel local impedance algorithm to guide effective pulmonary vein isolation in af patients: preliminary experience across different ablation sites from the charisma pilot study.J cardiovasc electrophysiol; year:2020;date:2020/07/03;volume:31;issue:9;pages:2319-2327 the charisma was a prospective, single-arm, multicenter cohort study designed to describe italian clinical practice regarding the approach to the ablation of different arrhythmias.The study com plied with the declaration of helsinki, the locally appointed ethics committee approved the research protocol, and informed consent was obtained from all patients.From july 2018 to october 2018, 46 consecutive patients indicated for af ablation who underwent high-resolution mapping and ablation in five italian centers were included in our analysis.All patients were followed-up at the same hospital, from the time of the first implantation to the last follow-up visit.After completion of the baseline evaluation, patients underwent the procedure under standard clinical practice guidelines.All procedures were performed under general anesthesia or deep conscious sedation.Vitamin k antagonist treatment was uninterrupted while non-vitamin k anticoagulants were omitted on the morning of the procedure.A decapolar catheter (dynamic xt; boston scientific, marlborough, ma, usa) was used to cannulate the coronary sinus.Single or double transseptal punctures were performed under fluoroscopic guidance, after which intravenous unfractionated heparin boluses were administered to maintain an activated clotting time of >300 s; the basket mapping catheter (orion; boston scientific) and the open-irrigated ablation catheter with three miniature electrodes incorporated within the distal tip electrode (intellanav mifi oi; boston scientific) were then inserted through steerable sheaths.To analyze the impedance information, the isolation line around each pair of pvs was divided into seven distinct sections.Successful single rf ablation was defined according to a reduction signal voltage by at least 50% and the inability to capture local tissue on pacing through the ablation catheter.Unsuccessful lesions were defined as those which resulted in continued ability to capture tissue.The endpoint of ablation was pvi, as assessed by entry and exit block using the 64-pole orion catheter placed sequentially in each of the pvs.The demographic and procedural data for the 46 consecutive patients.About two-thirds of the procedures were de novo pvi (n = 30, 65.2%).As the patient cohort included patients with persistent af (n = 22, 47.8%), the mean left atrium size was relatively large: 43 +/- 5 mm.The mean procedure duration and fluoroscopy times were 182.2 +/- 60 and 19.5 +/- 5 min, respectively.About 3072 rf applications were delivered, with a mean number of 48 +/- 26 ablation spots during a mean rf duration time of 39 +/- 30 s, without any steam popping.No steam pops or major complications, including atrioesophageal fistula or tamponade, were reported during or after the procedures.At the end of the procedures, all pvs were successfully isolated in all study patients.Minor complications were reported in four patients (8.7%) after the procedure: vascular complications in two patients (one groin hematoma and one arteriovenous fistula) and pericarditis with mild pericardial effusion in two patients.Conservative treatment and medical therapy were effective in all cases, without prolongation of hospital stay.During a mean follow- up of 404 +/- 111 days, four patients (9%) suffered af/at recurrence after the blanking period, resulting in a 91% recurrence-free rate of atrial arrhythmias.

• 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: 12415222
• MDR Text Key: 270505754
• Report Number: 2134265-2021-11181
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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: 08/18/2021
• 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
• Patient Outcome(s): Required Intervention