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 Arrhythmia (1721)

Event Date 01/09/2021

Event Type  Injury  

Manufacturer Narrative

Hadid, c., di toro, d., celano, l., martinenghi, n., antezana-chaves, e., gallino, s., dubner, s., & labadet, c.(2021).Catheter ablation of ventricular tachycardia in patients with electrical storm, with a special focus on patients with chagas disease.Journal of interventional cardiac electrophysiology, 62(3), 557-564.Https://doi.Org/10.1007/s10840-020-00915-7.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

The complaint is reportable as a serious injury.It was reported the patient experienced recurrent ventricular tachycardia and required a redo procedure due to ineffective treatment.Per literature review, it was reported that: in this single-center study at the hospital general de agudos cosme argerich, argentina, 38 patients treated for monomorphic ventricular tachycardia (vt) with electrical storm (es) using ablation were included.16 of the patients had chagas disease (chd).All of the patients were receiving antiarrhythmic drugs (aad): beta-blockers plus amiodarone.No patient had undergone a prior vt ablation.All procedures were performed using 3d mapping system.Intravenous heparin was administrated to maintain an activated clotting time between 250 and 350s.The ablation procedure was guided by electrophysiological mapping during vt with a 20-pole mapping catheter.During ablation, radiofrequency was delivered using irrigated-tip chilli ii catheter 40 w, 43c and a non boston scientific irrigated catheter; or 8-mm-tip catheter blazer ii 100 w, 65c in areas topographically corresponding with the vt origin.Ablation was performed targeting critical components of the vt circuit (e.G., isthmus of slow conduction), followed by substrate modification.After ablation, a monitoring zone was added to implantable cardioverter-defibrillator (icd) programming to detect vt faster than 120 beats per minute.Any sustained ventricular tachycardia/ventricular fibrillation episode recorded by the icd was considered as recurrence.Of the 38 patients that received treatment, 7 patients required a redo procedure due to vt recurrence.Three complications (6.5%) were observed: one femoral pseudoaneurysm (solved with mechanical compression); one electromechanical dissociation at the time of anesthetic induction (the patient recovered and the ablation procedure could be performed); and one patient underwent surgical exploration of the pericardial space after completion of epicardial ablation because of suspicion of right ventricular damage.Pericardial space was clean without right ventricle harm.Eleven patients (28.9%) died.Causes of death were heart failure (7), endocarditis 5 months post-ablation (1), pneumonia (1), and cancer (2).One patient could not be discharged due to several clinical intercurrences (such as heart failure, prolonged mechanical ventilation, renal disease, pneumonia, sepsis) and died 4 months after ablation.Furthermore, one patient underwent heart transplantation.Hadid, c., di toro, d., celano, l., martinenghi, n., antezana-chaves, e., gallino, s., dubner, s., & labadet, c.(2021).Catheter ablation of ventricular tachycardia in patients with electrical storm, with a special focus on patients with chagas disease.Journal of interventional cardiac electrophysiology, 62(3), 557-564.Https://doi.Org/10.1007/s10840-020-00915-7.

• 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: 18740229
• MDR Text Key: 335810705
• Report Number: 2124215-2024-09949
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• 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: 01/30/2024
• 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