MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARXFIT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Lot Number 0031431507

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

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 the review, a supplemental medwatch will be filled.

Event Description

It was reported that during a cryoablation procedure to treat atrial fibrillation (a fib) the crbs polarx fit balloon cath st ous was selected for use, the error message 1 - 00004000-2: console detected blood in the catheter was displayed.Error occurred during resheathing.The issue occurred when performing ablation multiple times and moving to the next ablation.It is unknown if blood was visible inside the catheter after error occurred, it cannot be confirmed visually.The troubleshooting was performed and the catheter was replaced.The procedure was completed successfully.No patient complications were reported.The device is expected to be returned for further analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected, the polarx device exhibited functional issues related to visible blood within the balloon region, indicating potential leakage or malfunction.To identify the source of the problem, both inner and outer balloons were pressurized.During this process, a leak was detected in the guidewire lumen, evidenced by bubbles emerging from the distal tip while pressurizing the inner balloon.The leak was pinpointed to the distal side of the marker band.The reported allegation of blood in catheter was confirmed, and the root cause was traced to device design.

Event Description

It was reported that during a cryoablation procedure to treat atrial fibrillation (a fib) the polarxfit was selected for use, error 1 - 00004000-2: console detected blood in the catheter occurred during resheathing.The troubleshooting was performed and the catheter was replaced.It is unknown if blood was visible inside the catheter after error occurred, it cannot be confirmed visually.The procedure was completed successfully.No patient complications were reported.The device was returned for analysis.

• Brand Name: POLARXFIT
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• 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: 18365416
• MDR Text Key: 331313948
• Report Number: 2124215-2023-72205
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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
• Device Operator: Health Professional
• Device Lot Number: 0031431507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1