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

Lot Number 0032683704

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 12/04/2023

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

It was reported that during a de novo cryoablation procedure to treat atrial fibrillation a polarx catheter was selected for use.During ablation the error message sn (b)(6) : the console detected blood in the catheter appeared on the console.The catheter was replaced and the procedure was completed.No patient complications were reported.It is unknown if blood was visible in the catheter.The device is expected to be returned for analysis.

Event Description

It was reported that during a de novo cryoablation procedure to treat atrial fibrillation a polarx catheter was selected for use.During ablation the error message sn 1 - (b)(6)-2: the console detected blood in the catheter appeared on the console.The catheter was replaced and the procedure was completed.No patient complications were reported.It is unknown if blood was visible in the catheter.The device was returned for analysis.

Manufacturer Narrative

The polarx catheter was returned to boston scientific for analysis.Upon receipt at the post market quality assurance laboratory the catheter underwent visual inspection, leakage testing, functional testing, and microscope inspection.No visible blood was seen inside the balloon and no external damage was noted.The device was assessed with an isaac pressure decay testing system to determine if any potential leak paths existed that may have contributed to the outer balloon high pressure in the field.The polarx device failed outer balloon vacuum leak testing with a gross leak.The polarx device was then connected to the smartfreeze console in attempt to recreate the blood detection error seen in the field.After multiple bending, steering, inflation, and slider switch manipulation cycles, the polarx did not trigger any blood detection errors.At this point, the device was fully assembled, and had not been dissected.The polarx device had a normal operational blood detect index of 21.The polarx device was then dissected, and the outer balloon line located inside of the handle was pressurized while submerged in water to locate a potential leak path.A leak path was found in the outer balloon itself.A small hole was found in the balloon which allowed fluid ingress, triggering a true blood detection error.The reported clinical observations were confirmed by the analysis.

• Brand Name: POLARX
• 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: 18351401
• MDR Text Key: 331069022
• Report Number: 2124215-2023-69867
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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: 0032683704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1