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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER OPEN-IRRIGATED; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BOSTON SCIENTIFIC CORPORATION BLAZER OPEN-IRRIGATED; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number 86490
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2023
Event Type  malfunction  
Event Description
It was reported that during an ablation procedure a blazer open-irrigated catheter was selected for use.The catheters tubing connector where the irrigation tubing is plugged was torn off during a movement.This forced to interrupt the procedure and replaced the defective catheter.After replacement, the procedure was completed successfully.No patient complications were reported.The device is not expected to be returned for analysis.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.
 
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Brand Name
BLAZER OPEN-IRRIGATED
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 DE COSTA RICA S.R.L.
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 Key17597715
MDR Text Key321684846
Report Number2124215-2023-44011
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number86490
Device Catalogue Number86490
Device Lot Number0029744863
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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