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

Model Number	85060
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
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 the catheter was fractured.During a procedure to treat paroxysmal supraventricular tachycardia (psvt), a blazer ii htd temperature ablation catheter was used.It was observed that the catheter was fractured.Another of the same device was used, and the procedure was completed without patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes the reported observation of catheter tears/rips/holes/separated device material was confirmed through investigational analysis.Device technical analysis: the blazer ii htd temperature ablation catheter was returned for analysis.Visual inspection of the returned product revealed that the device had a shaft cut, consequently confirming the reported complaint.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.Risk review: a review of the blazer ii htd temperature ablation catheter hazard analysis was completed and confirmed that the event of "catheter tears/rips/holes/separated device material" 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: based on the available information, boston scientific's investigation findings identified that the device shaft was cut.Therefore, this investigation is assigned a conclusion code of "unintended use error" which indicates that the event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that the catheter was fractured.During a procedure to treat paroxysmal supraventricular tachycardia, a blazer ii htd temperature ablation catheter was selected for use.It was observed that the catheter was fractured.No other information was provided.The procedure was completed with different device of the same model.There were no patient complications.The device is expected to be return 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24709244
• Report Number: 2124215-2026-16865
• Device Sequence Number: 10439965
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 85060
• Device Catalogue Number: 85060
• Device Lot Number: 0035892750
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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 Age: 64 YR
• Patient Sex: Male