MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II HTD TEMPERATURE ABLATION CATHETER; 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	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radio frequency ablation procedure using a blazer ii htd temperature ablation 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.
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.
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 of the catheter and found the catheter's steering worked as expected and no abnormal resistance was noted.They then tested the catheter's electrical circuits, and the device was found to be within specification.Finally, test ablations were performed with a known good system and the catheter performed as expected and no error messages or issues emerged.The returned blazer ii catheter was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.No problem was detected with the returned device that could have caused or contributed to the temperature issues seen in the field, nor were any other types of defects identified during the investigation.Ultimately the cause of the temperature error could not be determined.
Event or Problem Description
It was reported that during a radio frequency ablation procedure using a blazer ii htd temperature ablation 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 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: 18212414
• Report Number: 2124215-2023-66248
• Device Sequence Number: 7466728
• 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): 02/14/2024

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: 08/09/2024
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0027811393
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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: 71 YR
• Patient Sex: Male