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

Model Number	M0045031THN40
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1 initial reporter phone: (b)(6).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 broken.A blazer ii htd (high torque distal) catheter was selected for use.Upon receipt, it was observed that the catheter was broken, although, the packaging showed no signs of problems.The product is expected to be returned for analysis.
Additional Manufacturer Narrative
(b)(6).(report source, other) has been corrected.The blazer ii htd (high torque distal) catheter has not been received for analysis; however, photos of the complaint device were provided.Media inspection confirmed the reported event of catheter shaft tears/rips/holes/sep dev matrl.The investigation findings did not lead to a clear conclusion about the cause of the reported event; without analysis of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable root cause of the event.
Event or Problem Description
It was reported that the catheter was broken.A blazer ii htd (high torque distal) catheter was selected for use.Upon receipt, it was observed that the catheter was broken, although, the packaging showed no signs of problems.The product is expected to be returned for analysis.

• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23785397
• Report Number: 2124215-2025-90279
• Device Sequence Number: 5128830
• Product Code: LPB
• UDI-Device Identifier: 08714729172093
• UDI-Public: (01)08714729172093(17)251205(10)30661042
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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 Expiration Date: 12/05/2025
• Device Model Number: M0045031THN40
• Device Catalogue Number: M0045031THN40
• Device Lot Number: 0030661042
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 04/30/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/05/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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