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

Model Number	85056
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.
Event or Problem Description
It was reported that during a procedure using a blazer ii htd catheter a temperature error occurred.It was unknown what type of error was displayed.They exchanged the catheter and the issue was resolved.The procedure was then completed with no patient complications.The catheter is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected, and no abnormalities were found.Next, they functionally tested the steering mechanisms of the catheter and found them to function properly.Then, the lumen of the catheter was tested for leaks, the lumen was uncompromised, and the device passed leak testing.Next, the catheter was electrically examined and no shorts or opens were found.Finally, they connected the catheter to a known good radio frequency generator for a test ablation.The temperature and power output were within specifications and no error messages occurred during the test.With all available information the allegation of poor temperature control could not be confirmed as the failure was not able to be reproduced and the device presented with no issues.
Event or Problem Description
It was reported that during a procedure using a blazer ii htd catheter a temperature error occurred.They exchanged the catheter and the issue was resolved.The procedure was then completed with no patient complications.The catheter 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17268266
• Report Number: 2124215-2023-34136
• Device Sequence Number: 5960112
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: 08/10/2024
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0027818716
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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: 69 YR
• Patient Sex: Male