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

Model Number	85016
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The blazer catheter was selected for use during the procedure to treat paroxysmal supraventricular tachycardia.It was reported that the temperature couldn't exceed 40 degrees celsius.Replacing the catheter resolved the issue.The procedure was completed successfully.No patient complications were reported.The device 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
Correction to lot number.
Event or Problem Description
The blazer catheter was selected for use during the procedure to treat paroxysmal supraventricular tachycardia.It was reported that the temperature couldn't exceed 40 celcius.Replacing the catheter resolved the issue.The procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.
Event or Problem Description
The blazer catheter was selected for use during the procedure to treat paroxysmal supraventricular tachycardia.It was reported that the temperature couldn't exceed 40 celcius.Replacing the catheter resolved the issue.The procedure was completed successfully.No patient complications were reported.The device was returned for laboratory analysis.
Additional Manufacturer Narrative
Correction: section d.Suspected medical device; d4 lot number: 0027587984.Blazer ii xp catheter was evaluated by boston scientific.Analysis of returned product revealed that the device has an electrical open on the resistor id, consequently confirming the reported complaint.Additionally, the device was destructively analyzed, and it was observed that the resistor id electrical open is located at distal section of the catheter.Laboratory analysis was able to confirm the reported clinical observation of poor temperature control.

• Brand Name: BLAZER II 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19624243
• Report Number: 2124215-2024-39372
• Device Sequence Number: 12370582
• Product Code: LPB
• UDI-Device Identifier: 08714729082811
• UDI-Public: 08714729082811
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 09/20/2024

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: 06/29/2024
• Device Model Number: 85016
• Device Catalogue Number: 85016
• Device Lot Number: 0027587984
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 08/02/2024; 08/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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 Sex: Unknown