MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV CATHETERS; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

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

Patient Problem Cardiac Tamponade (2226)

Event Date 06/07/2022

Event Type  Injury  

Event Description

Per literature review, it was reported that: at gunma prefectural cardiovascular center from september 2019 to november 2020, 157 patients were enrolled to this study who were scheduled to undergo an initial extensive pvi of af guided by the rhythmia system, using the intellanav mifi open-irrigated ablation catheter.All patients underwent transesophageal and or intracardiac echocardiography to rule out any intracardiac thrombi before the ablation procedure and contrast-enhanced computed tomography (ct) or plain magnetic resonance (mr) imaging for assessment of the pulmonary vein and left atrium anatomy.During the ablation procedure, the activated clotting time was maintained between 300 and 400 s by a continuous and additional bolus heparin infusion.All patients received deep conscious sedation throughout the procedure using propofol or dexmedetomidine, and pentazocine.The catheter was introduced into the left atrium through three transseptal sheaths (non-boston scientific brand).The pvo started in an order from right pulmonary veins (rpv) to left pulmonary veins (lpv) in 76 patients and from the lpvs to rpvs in 81 patients and was successfully completed in all patients.A total of 28 patients underwent additional ablation procedures other than the pvi and cavo tricuspid isthmus linear ablation.Procedure-related complications occurred in four patients: a cardiac tamponade in one, which could be managed with percutaneous pericardial drainage, gastric hypomotility in two, which spontaneously resolved, and a femoral hematoma in one, which could be managed with a local pressure application.All endocardial residual and reconnected gaps were successfully eliminated with rf applications at the gap sites on the initial pvi lines.Nakamura k, sasaki t, minami k, et al., prevalence, characteristics, and predictors of endocardial and non-endocardial conduction gaps during local impedance-guided extensive pulmonary vein isolation of atrial fibrillation with high-resolution mapping.J cardiovasc electrophysiol.2021;32: 2045-2059.Https://doi.Org/10.1111/jce.15152.

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 CATHETERS
• 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: 18194318
• MDR Text Key: 328825114
• Report Number: 2124215-2023-66033
• 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: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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: 11/17/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male