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

Lot Number 0031407259

Device Problems Device Contamination with Body Fluid (2317); Infusion or Flow Problem (2964)

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

Event Date 08/24/2023

Event Type  malfunction  

Event Description

It was reported that at closure of a cryo ablation procedure to treat an atrial fibrillation a crbs polarx fit balloon cath st presented an issue.After ablation on the right superior pulmonary vein (rspv) an error "sn (b)(6): the console detected a problem with the blood detection circuit in the catheter" occurred.The procedure itself was already completed, so the catheter was immediately removed from the patient.After removal, blood was confirmed inside the catheter.No patient complications were reported.The catheter has been received at boston scientific and its waiting for laboratory analysis.

Event Description

It was reported that at closure of a cryo ablation procedure to treat an atrial fibrillation a crbs polarx fit balloon cath st presented an issue.After ablation on the right superior pulmonary vein (rspv) an error "sn (b)(6): the console detected a problem with the blood detection circuit in the catheter" occurred.The procedure itself was already completed, so the catheter was immediately removed from the patient.After removal, blood was confirmed inside the catheter.No patient complications were reported.The device has been received at a boston scientific post market laboratory.

Manufacturer Narrative

Polarx fit balloon cath st was evaluated by boston scientific.Visual inspection noted that there was visible blood was seen inside the balloon and no external damage was noted.The device was not assessed with an isaac pressure decay testing system to determine if any potential leak paths existed that may have contributed to the blood detection error in the field, as there was visible blood inside the balloon region.The catheter handle was opened to further investigate the breach leading to the blood inside the balloon.A leak was found while pressurizing the inner balloon leaking out the distal tip of the guidewire lumen.A leak path was found in the adhesive on the distal side of the marker band.This is a known failure spot.When an ablation is performed, the adhesive freezes and with manipulation can lead to the guidewire lumen cracking and creating a leak path.The reported allegation of a blood detection error was confirmed.

• 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: 17745133
• MDR Text Key: 323396686
• Report Number: 2124215-2023-50123
• 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: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0031407259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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