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

Lot Number 0031424461

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 12/11/2023

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 that review, a supplemental medwatch will be filed.

Event Description

During a ablation procedure a polarxfit catheter was selected for use.After ablation was complete in the left pulmonary vein (lpv) and as the catheter was moved to the right pulmonary vein (rpv), an error code 1-00004000-2 blood in the catheter has appeared.It is unknown if blood was visible.The catheter was removed outside the patient and reconnection was performed, but there was no improvement.The catheter was replaced, and the and the procedure was completed.No patient complications were reported.The catheter is expected to return.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory.Visual inspection revealed no visible blood was seen inside the balloon and no external damage was noted.Leak testing was performed to determine if any potential leak paths existed that may have contributed to the blood detection error in the field.The catheter did not reveal any leak paths related to the blood detection failure.Functional testing revealed after multiple bending, steering, inflation, and slider switch manipulation cycles, the polarx did not trigger any blood detection errors.The polarx was then dissected to further investigate blood detect wires for symptoms that may have resulted in the blood detection error.The inner balloon blood detect wires were split.This wire split could lead to the wires contacting each other which would result in a false blood detection error.The allegation of blood detect was confirmed.

Event Description

During a ablation procedure a polarxfit catheter was selected for use.When left pulmonary vein cooling ended and onto the right pulmonary vein an error code 1-00004000-2 blood in the catheter has appeared.It is unknown if blood was visible.The catheter was removed outside the patient and reconnection was performed, but there was no improvement.The catheter was replaced, and the and the procedure was completed.No patient complications were reported.The catheter is expected to return.

• 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: 18382839
• MDR Text Key: 331197765
• Report Number: 2124215-2023-73248
• 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: 03/01/2024

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: 0031424461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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