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

Model Number	85080
Medical Device Problem Codes	Output Problem (3005); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure to treat paroxysmal supraventricular tachycardia, a blazer ii htd catheter was selected for use.It was reported that the power did not increase during procedure.Procedure was completed with another of same device.No patient injury reported.
Additional Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
During an ablation procedure to treat paroxysmal supraventricular tachycardia, a blazer ii htd catheter was selected for use.It was reported that the power did not increase during procedure.Procedure was completed with another of same device.No patient injury reported.
Additional Manufacturer Narrative
The blazer catheter was returned to boston scientific for analysis.Visual inspection did not reveal any defects or abnormalities.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.The continuity test was performed and the device is under specification.No opens or shorts were detected.Test ablations were performed by connecting the catheter to a maestro generator 4000 and the device was found within specifications.The device passed all relevant testing and the reported event was not confirmed.

• Brand Name: BLAZER II HTD
• Common Device Name: 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: 13794689
• Report Number: 2134265-2022-03009
• Device Sequence Number: 12027669
• Product Code: LPB
• UDI-Device Identifier: 08714729333326
• UDI-Public: 08714729333326
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2024
• Device Model Number: 85080
• Device Catalogue Number: 85080
• Device Lot Number: 0027955109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male