MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARX FIT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	M004CRBS2060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Blood detected in balloon catheter - alert given on console during case, while catheter was in body.Catheter removed, replaced with a new one.No patient harm.Doctor was present.Manufacturer representative called into his company.

• Brand Name: POLARX FIT
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 18534035
• Report Number: 18534035
• Device Sequence Number: 17811480
• Product Code: OAE
• UDI-Device Identifier: 08714729992622
• UDI-Public: (01)08714729992622
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/04/2024
• Report Date (Section F): 01/04/2024

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 Model Number: M004CRBS2060
• Device Catalogue Number: M004CRBS2060
• Device Lot Number: 32276258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Race: White
• Date Report Sent to FDA: 01/04/2024