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

Lot Number 0031776980

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 12/12/2023

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 an atrial fibrillation procedure a polarx balloon catheter was selected for use.When the physician tried to inflate balloon in the left inferior pulmonary vein (lipv) a blood detection error (error 1-00004000-2) occurred.Blood was visible within the balloon.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.

Manufacturer Narrative

Polarx balloon catheter 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.No leaks were observed, but it was noticed that blood was only visible in the inner balloon.The blood in the inner balloon is believed to be caused by a short guidewire lumen braid termination which was found to be out of specification.

Event Description

It was reported that during an atrial fibrillation procedure a crbs polarx balloon catheter st was selected for use.A blood detection error has occurred.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device has been received at boston scientific post market laboratory.

• 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: 18386713
• MDR Text Key: 331497182
• Report Number: 2124215-2023-73153
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/22/2024

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 Expiration Date: 04/18/2024
• Device Lot Number: 0031776980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1