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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BOSTON SCIENTIFIC CORPORATION BLAZER II; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number 85020
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported the catheter was unable to sense temperature.During an ablation procedure to treat supraventricular tachycardia (svt) in the left atrium (la), the physician was unable to ablate with two different blazer ii 4mm catheters.The catheters were not sensing temperature at all.The impedance was sensing appropriately, but because temperature was not, they were unable to ablate.An attempt at ablation was made but was unsuccessful.There was no mapping system involved, this was a conventional electrophysiology (ep) procedure.The ablation time was 0 seconds when the issue occurred.The issue was persistent from the start of ablation and therefore the catheters were not usable.The generator was used in power mode, but it was unknown at what output.No error message displayed.No patient complications occurred.The procedure was completed with another manufacturer's catheter.
 
Manufacturer Narrative
The device was received at boston scientific for evaluation.Visual inspection showed the device did not have visual defects.Functional testing showed the steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.An electrical test was performed and the device was found within specification.No opens or shorts were found.A radiofrequency (rf) ablation test using the maestro generator 4000 found the device was within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported the catheter was unable to sense temperature.During an ablation procedure to treat supraventricular tachycardia (svt) in the left atrium (la), the physician was unable to ablate with two different blazer ii 4mm catheters.The catheters were not sensing temperature at all.The impedance was sensing appropriately, but because temperature was not, they were unable to ablate.An attempt at ablation was made but was unsuccessful.There was no mapping system involved, this was a conventional electrophysiology (ep) procedure.The ablation time was 0 seconds when the issue occurred.The issue was persistent from the start of ablation and therefore the catheters were not usable.The generator was used in power mode, but it was unknown at what output.No error message displayed.No patient complications occurred.The procedure was completed with another manufacturer's catheter.
 
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Brand Name
BLAZER II
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9849997
MDR Text Key184039960
Report Number2134265-2020-03533
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/02/2022
Device Model Number85020
Device Catalogue Number85020
Device Lot Number0023740787
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2020
Date Manufacturer Received04/29/2020
Patient Sequence Number1
Treatment
BIOSENSE WEBSTER SMARTABLATE GENERATOR; BIOSENSE WEBSTER SMARTABLATE GENERATOR; BLAZER II CATHETER; BLAZER II CATHETER
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