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

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

Patient Problems Pericardial Effusion (3271); Heart Block (4444)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: the event date is unknown.The device is not expected to be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

Brown mt, kiani s, black gb, lu mlr, lloyd m, leon ar, shah a, westerman s, merchant fm, el-chami m.Ablation of manifest septal accessory pathways: a single-center experience.J interv card electrophysiol.2020.Thirty-three patients underwent an electrophysiologic study (eps) for symptomatic wpw syndrome and septal accessory pathways (sap).The mean age was 34.9 +/- 12.1 (17-65) years, and 6 had htn, and only 1 had cad.Patients presented with palpitations and/or history of supraventricular tachycardia (svt) in the majority of patients (93.9%), and nearly one-third had a history of syncope.Medical therapy included 12 patients on beta blockers, 5 on antiarrhythmic drugs (aad), and 2 on calcium channel blockers (ccb) prior to ablation.Three patients were on combination of medicines (class ic aads combined with a beta blockers or ccb).Seventeen patients were on no medical treatment prior to ablation.Ten patients had failed ablations elsewhere and were referred for another attempt to our center.Failure to eliminate preexcitation in 8 patients and proximity to the conduction system in 2 patients were the reasons for failed procedure.All patients met the diagnostic criteria of wpw syndrome.Thirteen patients had an anteroseptal (as) accessory pathway (ap).Three patients had a nonmalignant ap and no inducible svt during the eps.No ablation was performed on these patients.Ten patients underwent an eps and an ablation.Ablation was successful in 9/10 patients.For the patient with unsuccessful ablation, mechanical bumping transiently eliminated the pathway.Ap conduction did not recur during the study, and procedure was aborted.The pathway recurred overnight (during hospitalization), and a redo eps/ablation was performed the next day.Cryoablation completely eliminated the pathway without any recurrence.The remaining 9 underwent successful ablation procedure.Cryoablation was used solely during 4 out of the 11 ablations.In 4 ablations, both cryo and rf catheters were used for ablation, and in 3 procedures, only rf ablation was used.In one patient, ablation with rf was successful at the noncoronary cusp (ncc).In two patients, mapping at the ncc was performed, but successful ablation was performed in the right anteroseptal region.The reasons for using both cryo and rf catheters during 4 ablation procedures included the following: in 2 ablations, the ap was deemed too close to the his bundle area, and the operator shifted to a cryo catheter.In the remaining 2 ablations, cryo failed to eliminate ap conduction, and an 8-mm rf ablation catheter successfully eliminated the ap.In 3 patients using cryo mapping, transient high-grade av block was seen, and transient pr prolongation in the first 30s of cryo application was noted to precede heart block.This effect quickly resolved once cryoablation was turned off and av block resolved.In these 3 cases, ap conduction was eliminated during cryoablation, and additional bonus cryo lesions were delivered typically in the same location with close monitoring of the pr interval without any recurrence of heart block.No cases of permanent av block were seen.During a mean follow-up of 645 days, only one patient had recurrent pathway conduction.The decision was made to treat this patient with flecainide.Fifteen patients with a ps ap had an eps.Ablation was successful in 14 out of 15 patients.Three patients had a successful ablation in the left ps, while the rest had a successful ablation at the right ps.The ablation failed in one patient due to recurrent accelerated junctional rhythm during rf application with retrograde block.Reattempt ablation was done during a second procedure with the plan to use cryo catheter, but the patient had significant groin discomfort during the procedure which led to early termination of the procedure.This patient was treated medically.One patient with a ps and right free wall ap and multiple prior failed ablations in other centers had epicardial and endocardial mapping and ablation at our center.A pericardial effusion developed after pulling the pericardial drain that required a pericardial window.However, both accessory pathways were successfully treated in this patient.Mean ablation duration time was 2:03 +/- 1:02 h, and mean fluoroscopy time was 22.6 +/- 19.1 min for the entire cohort.

• Brand Name: BLAZER II
• 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: 11386256
• MDR Text Key: 233806766
• Report Number: 2134265-2021-02492
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 02/12/2021
• 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): Other; Required Intervention