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

Model Number	87120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a cavotricuspid isthmus ablation procedure to treat paroxysmal atrial fibrillation a blazer prime htd temperature ablation catheter was selected for use.The connection between the catheter handle and shaft broke.The procedure was completed using the same catheter.No patient complications.The device is not expected to be returned for analysis due to disposal.

• Brand Name: BLAZER PRIME 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: 18182216
• Report Number: 2124215-2023-65551
• Device Sequence Number: 20805782
• Product Code: LPB
• UDI-Device Identifier: 08714729803614
• UDI-Public: 08714729803614
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/21/2023

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: 06/22/2025
• Device Model Number: 87120
• Device Catalogue Number: 87120
• Device Lot Number: 0029645802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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