MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; UNKNOWN DECAPOLAR CATHETER

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

Patient Problems Arrhythmia (1721); Cardiac Tamponade (2226); Complaint, Ill-Defined (2331)

Event Date 09/01/2008

Event Type  Injury  

Manufacturer Narrative

Citation: lee, kwang-no et al.(2018) long-term clinical comparison of procedural end points after pulmonary vein isolation in paroxysmal atrial fibrillation.Circulation: arrhythmia and electrophysiology, 11(2).Doi: 10.1161/circep.117.005019.

Event Description

Reported via journal article.Background: pulmonary vein isolation (pvi) is effective for maintenance of sinus rhythm in 50% to 75% of patients with paroxysmal atrial fibrillation, and it is not uncommon for patients to require additional ablation after pvi.We prospectively evaluated the relative effectiveness of 2 post-pvi ablation strategies in paroxysmal atrial fibrillation.Methods and results: a total of 500 patients were randomly assigned to undergo ablation by 2 different strategies after pvi: (1) elimination of non-pv triggers or (2) stepwise substrate modification including complex fractionated atrial electrogram or linear ablation until noninducibility of atrial tachyarrhythmia was achieved.During a median follow-up of 26.0 months, 75 patients experienced at least 1 episode of recurrent atrial tachyarrhythmia after the single procedure in group a compared with 105 patients in group b.Competing risk analysis showed that the cumulative incidence of atrial tachycardia was significantly higher in group b compared with group a.With the exception of total ablation time, there were no significant differences in fluoroscopic time or procedure-related complications between the 2 groups.Conclusions: elimination of triggers as an end point of ablation in patients with paroxysmal atrial fibrillation decreased long-term recurrence of atrial tachyarrhythmia compared with a noninducibility approach achieved by additional empirical ablation.The post-pvi trigger test is thus a better end point of ablation for paroxysmal atrial fibrillation.The source literature reported intracardiac electrograms at the high right atrium, low right atrium, and coronary sinus were mapped with a decapolar catheter.Of 500 patients enrolled, 42 patients experienced procedure related complications.The most common complication was hemopericardium resulting in cardiac tamponade.In group b, 10 cases of cardiac tamponade or hemopericardium occurred, one case of pr interval prolongation occurred, and 48 patients underwent internal cardioversion to terminate sustained atrial arrhythmias.Mean patient age was 55.7 years, and the patient population was 74.6% male.

• Type of Device: UNKNOWN DECAPOLAR CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC; 4100 hamline ave n; st paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8019611
• MDR Text Key: 125492619
• Report Number: 2134265-2018-62407
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2018

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: 10/08/2018
• Initial Date FDA Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other