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

Model Number	85056
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
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
The blazer temperature ablation catheter was selected for use during the ablation procedure.It was reported that foreign substance was observed in the catheter handle.The device was replaced with a new one from the same model.The procedure was completed successfully without patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed and the device has adhesive residue on the handler.Functional testing was performed and revealed that the steering knob and the tension control knob functioned properly.No abnormal resistance was felt when actuating the steering mechanism.With all the available information, boston scientific concludes the reported event of foreign substance on the catheter handle was confirmed.
Event or Problem Description
The blazer temperature ablation catheter was selected for use during the ablation procedure.It was reported that foreign substance was observed in the catheter handle.The device was replaced with a new one from the same model.The 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: 18751614
• Report Number: 2124215-2024-08591
• Device Sequence Number: 14387782
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: 08714729172048
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 08/24/2026
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0032296505
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 04/13/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown