MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER PRIME XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	87152
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
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.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that during an ablation procedure using a blazer prime xp catheter to treat atrial fibrillation the tip of the catheter tip became deformed and unable to be straightened.The issue arose approximately an hour into the procedure.They exchanged the catheter and were able to complete the procedure without patient complications.The catheter is not expected to be returned for analysis as it was discarded at the facility.

• Brand Name: BLAZER PRIME XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 12885341
• Report Number: 2134265-2021-14828
• Device Sequence Number: 3961303
• Product Code: OAD
• UDI-Device Identifier: 08714729802372
• UDI-Public: 08714729802372
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

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: 07/02/2023
• Device Model Number: 87152
• Device Catalogue Number: 87152
• Device Lot Number: 0025666863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• 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