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

Model Number	85020
Medical Device Problem Codes	Failure to Deliver Energy (1211); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cardiac radiofrequency ablation, a blazer ii catheter was selected for use.During the procedure, ablation the discharge was abnormal, and the adjustment of the tail line could not be solved.The catheter was replaced and the procedure was completed without any patient complications.This catheter is expected to be returned for laboratory 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.
Event or Problem Description
It was reported that during a cardiac radiofrequency ablation, a blazer ii catheter was selected for use.During the procedure, ablation the discharge was abnormal, and the adjustment of the tail line could not be solved.The catheter was replaced and the procedure was completed without any patient complications.This catheter has been returned for laboratory analysis.
Additional Manufacturer Narrative
The device has been returned for laboratory analysis.Visual inspection did not reveal any abnormalities.Functional testing noted no abnormal resistance while maneuvering the catheter.Electrical and continuity testing were performed, and the device showed all results were within specifications.Laboratory analysis was unable to confirm the reported clinical observations; the device passed all relevant testing.Correction: the field f10 device code has been changed from "defective device a0203" to "failure to deliver energy a090402".

• Brand Name: BLAZER II
• 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: 15276427
• Report Number: 2124215-2022-32066
• Device Sequence Number: 6486077
• Product Code: LPB
• UDI-Device Identifier: 08714729082439
• UDI-Public: 08714729082439
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/11/2022

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: 08/12/2022
• Device Model Number: 85020
• Device Catalogue Number: 85020
• Device Lot Number: 0024262328
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 80 KG