MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARX

Model Number M004CRBS2000

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 06/22/2021

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 a polarx was used in a paroxysmal atrial fibrillation ablation procedure.It was noted that the error 1 - 00004000-2: console detected blood in the catheter occurred after ablating the left veins successfully.The physician left the catheter with out movements in the atrium to check act of blood.Upon removal of the catheter, it was noted that blood was visible inside the balloon.The polarx was exchanged and the procedure was completed successfully.

Manufacturer Narrative

The polarx device it not approved in the us and has no similar products in the us.The report was submitted in error, as us mdr reporting is not required.Visual inspection of the device showed blood residues visible within the balloon region with no other external abnormalities were noted.A micro fissure breach was noted in the outer balloon near the distal section.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a polarx was used in a paroxysmal atrial fibrillation ablation procedure.It was noted that that the error 1 - 00004000-2: console detected blood in the catheter occurred after ablating the left veins successfully.The physician left the catheter with out movements in the atrium to check act of blood.Upon removal of the catheter, it was noted that blood was visible inside the balloon.The polarx was exchanged and the procedure was completed successfully.

• Brand Name: POLARX
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 12128091
• MDR Text Key: 262632592
• Report Number: 2134265-2021-08632
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2022
• Device Model Number: M004CRBS2000
• Device Lot Number: 0026896742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Date Manufacturer Received: 08/04/2021
• Patient Sequence Number: 1