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

Lot Number 0031414757

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 10/31/2023

Event Type  malfunction  

Manufacturer Narrative

The polarx catheter was visually inspected in attempt to identify the cause for the blood detection error seen in the field.Visible blood was seen inside the balloon and no external damage was noted.Due to visible blood the device was not leak tested.The device was hooked up to the smartfreze console to observe the blood index.It was not console tested and was not connected through a cryo-cable as there was blood in the balloon region.The blood index read a nominal value of 20.The polarx device was dissected, the outer balloon line located inside of the handle was cut distal to the check valve.The outer balloon line was pressurized to locate a leak path.A leak path was found in the outer balloon itself.The reported event was confirmed.

Event Description

Reportable based on analysis completed on 07 december 2023 it was reported that during a percutaneous myocardial ablation a polarx fit balloon was selected for use.After performing cryo treatment, and approaching lspv, the error code "(b)(6): the console detected blood in the catheter" suddenly appeared.Troubleshooting did not solve the issue, so the catheter was replaced.The procedure was completed successfully.No patient complications were reported.No blood was confirmed visually.However, analysis of the returned device revealed visible blood was seen inside the balloon due to an outer balloon leak.

• 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: 18378128
• MDR Text Key: 331384074
• Report Number: 2124215-2023-73136
• 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
• Report Date: 12/21/2023

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?: No
• Device Operator: Health Professional
• Device Lot Number: 0031414757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1