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

Model Number	M0045031THK20
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been evaluated.Upon 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 or Problem Description
It was reported that the energy did not increase.A blazer ii htd temperature ablation catheter was selected for use.It was noted that the energy did not increase.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.The device has been received, pending analysis.
Event or Problem Description
It was reported that the energy did not increase.A blazer ii htd temperature ablation catheter was selected for use.It was noted that the energy did not increase.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.The device has been received and analyzed.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the returned blazer ii htd temperature ablation catheter was visually inspected, and no problems were observed.Functional testing revealed that the catheter functional mechanism worked properly; no abnormal resistance was felt when actuating the device.Continuity testing was performed, and the device was found within specifications.Electrical testing was also performed, the ablation was verified using the maestro generator 400, and the device was found within specifications.With all available information, the reported event of generator low power could not be confirmed as this was not able to be reproduced, and the device presented with no issues.

• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23672102
• Report Number: 2124215-2025-86095
• Device Sequence Number: 9708226
• Product Code: LPB
• UDI-Device Identifier: 08714729172055
• UDI-Public: (01)08714729172055(17)280219(10)35892750
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 Model Number: M0045031THK20
• Device Catalogue Number: M0045031THK20
• Device Lot Number: 0035892750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown