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

Model Number	M0045031T0
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there was no change in the temperature.A blazer ii temperature ablation catheter was selected for use.It was observed that there was no change in the temperature.There were no patient complications reported as a result of this event.No information has been provided at this time regarding the outcome of the procedure.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that there was no change in the temperature.A blazer ii temperature ablation catheter was selected for use.It was observed that there was no change in the temperature.There were no patient complications reported as a result of this event.No information has been provided at this time regarding the outcome of the procedure.The device has been received and analyzed.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported event of temperature cath-poor temperature control could not be confirmed, as no device problems were identified during analysis.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: upon receipt at post market quality assurance laboratory, the blazer ii temperature ablation catheter was visually inspected, and no visible problems were noted.Functional testing revealed that the catheter's 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 performed by using a maestro generator 4000, and the device was also found within specifications.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the blazer ii temperature ablation catheter risk documentation was completed and confirmed that the event of temperature cath-poor temperature control was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific has assigned an investigation conclusion code of no problem detected, as the investigation findings confirmed that no problems were identified with the device.

• Brand Name: BLAZER II 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: 24204635
• Report Number: 2124215-2026-05157
• Device Sequence Number: 18527698
• Product Code: LPB
• UDI-Device Identifier: 08714729082811
• UDI-Public: (01)08714729082811(17)270408(10)33780439
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: M0045031T0
• Device Catalogue Number: M0045031T0
• Device Lot Number: 0033780439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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