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

Model Number	85060
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The blazer ii htd temperature ablation catheter was selected for use during the procedure to treat paroxysmal supraventricular tachycardia.It was reported that the temperature would fluctuate multiple times.After the temperature rose above 70 degrees, they slowly turned it on, but the power was fixed at 10watt and they did not see any rise.A different device was used and procedure was completed successfully without patient complications.The device is excepted to be returned for analysis.
Additional 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.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed the device did not have visual defects.Functional testing showed that the steering knob and the tension control knob functioned properly.No abnormal resistance was felt when actuating the steering mechanism.The continuity test was performed, and the device is under specification.A radiofrequency (rf) ablation test was verified by using the maestro generator 4000, and the device was found within specifications.
Event or Problem Description
The blazer ii htd temperature ablation catheter was selected for use during the procedure to treat paroxysmal supraventricular tachycardia.It was reported that the temperature would fluctuate multiple times.After the temperature rose above 70 degrees, they slowly turned it on, but the power was fixed at 10watt, and they did not see any rise.A different device was used, and procedure was completed successfully without patient complications.The device is expected to be returned for analysis.

• Brand Name: BLAZER II HTD TEMPERATURE ABLATION CATHETER
• 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: 18849398
• Report Number: 2124215-2024-12479
• Device Sequence Number: 7133096
• Product Code: LPB
• UDI-Device Identifier: 08714729172055
• UDI-Public: 08714729172055
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 09/12/2026
• Device Model Number: 85060
• Device Catalogue Number: 85060
• Device Lot Number: 0032420082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown