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

Lot Number 0032934927

Device Problem Infusion or Flow Problem (2964)

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

Event Date 01/11/2024

Event Type  malfunction  

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.The outer balloon line located inside of the handle was pressurized to locate a leak path.A leak path was found in the outer balloon itself.The reported allegation of a blood detection error was confirmed.

Event Description

Reportable based on analysis completed on 14feb2024.It was reported that during preparation for an atrial fibrillation procedure a crbs polarx fit st was selected for use.After connecting the catheter to the console, a blood detection circuit error occurred.High refrigerant flow message appeared briefly, but messaged disappeared and did not affected procedure.The catheter was replaced and the error was cleared.The procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.However, analysis of the returned device revealed visible blood ingress into the balloon.

• 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: 18849528
• MDR Text Key: 337622534
• Report Number: 2124215-2024-13129
• 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
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0032934927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1