MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II TEMPERATURE ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

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

Patient Problem Ventricular Fibrillation (2130)

Event Date 10/22/2021

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

It was reported the patient experienced ventricular fibrillation that required cardioversion.Per literature review, it was reported that: in this single-center study at the university of fukui, japan, 1078 patients underwent a cti (cavotricuspid isthmus) ablation using radiofrequency ablation between january 2012 and december 2020.All procedures were performed under mild or moderate sedation obtained with dexmedetomidine.A 10 or 20-pole catheter was inserted into the coronary sinus (cs) through the right jugular vein or right femoral vein.In patients with atrial fibrillation (af), pulmonary vein isolation was performed using an irrigated-tip catheter under the guidance of a non-boston scientific 3d mapping system or non-boston scientific cryoballoon catheter.Additional ablation targeting af triggers from non pulmonary vein foci and a left atrium substrate modification was performed at the discretion of the operator.Subsequently, a decapolar mapping catheter was placed in the lateral right atrium (ra).During ablation, a linear lesion was created from the tricuspid annulus to the inferior vena cava in a point-by-point fashion without the use of a steerable sheath except in specific cases.The duration of each radiofrequency (rf) application was 30-60s.The maximum power output was 70, 50, and 30-35w, and the temperature limit was 70, 55, and 43 degrees, when using 10-mm tip (intellatipmifi xp, boston scientific), 8-mm tip (non-boston scientific, and blazer ii, boston scientific), and 3.5/4.0/4.5-mm tip irrigated-tip catheters (non-boston scientific catheters and intellanav mifi oi, boston scientific), respectively.The above-mentioned power settings for each catheter with a different tip size were decided to obtain a similar current density at the tip.In cryoablation, the individual lesions were placed in a point-by-point fashion with a non-boston scientific 8-mm tip cryocatheter for a duration of 120s with a steerable sheath.The endpoint of the procedure was the achievement of bidirectional conduction block along the cti.Of the 1078 patients that received treatment, 187 underwent repeat procedures for recurrent arrhythmias.Procedure-related complications occurred in 15 (1.4%) patients.Eight patients experienced coronary artery spasms with significant st-segment elevation in the inferior leads.One patient exhibited ventricular fibrillation requiring electrical cardioversion following the st elevation on the ward after the procedure.Five patients experienced transient atrioventricular block, where all recovered without any specific treatment.The last patient experienced cardiac tamponade requiring drainage due to a steam pop during the rf application with a non-boston scientific irrigated tip catheter.No patients suffered major complications (bleeding requiring thoracotomy or transfusion, permanent phrenic nerve paralysis, pacemaker device implantation, stroke/transient ischemic attack, atrio-esophageal fistulate requiring surgery, death) during or after the ablation.Kakehashi, s., miyazaki, s., hasegawa, k., nodera, m., mukai, m., aoyama, d., nagao, m., sekihara, t., eguchi, t., yamaguchi, j., shiomi, y., tama, n., ikeda, h., ishida, k., uzui, h., & tada, h.(2021).Safety and durability of cavo-tricuspid isthmus linear ablation in the current era: single-center 9-year experience from 1078 procedures.Journal of cardiovascular electrophysiology, 33(1), 40-45.

• Brand Name: BLAZER II TEMPERATURE ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 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: 18597774
• MDR Text Key: 334040594
• Report Number: 2124215-2024-04292
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• 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: 01/15/2024
• 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