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

Model Number M004CRBS3050

Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Event Description

During an ablation procedure to treat paroxysmal atrial fibrillation a polarsheath was selected for use.The polarsheath was prepped as recommended and inserted into the left atrium.It was reported that when the dilator was slowly removed, blood was leaking from the hemostatic valve.The sheath was exchanged and the procedure resumed.It was also reported that the related ep xt diagnostic catheter was kinked and the steer was not functioning appropriately after it was removed from the packaging.The physician attempted to use the catheter, however, the desired position was unable to be reached.The catheter was exchanged.The procedure resumed and was completed successfully without any patient complications.

Manufacturer Narrative

With all the available information, boston scientific concludes the reported observation of sheath leak was not confirmed through investigational analysis.The device was returned to boston scientific for analysis.Visual inspection noted a small tear on the outer slit of the hemostatic valve.The device passed all standard and extensive testing procedures for pressure decay, aspiration, and hemostasis.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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

Polar ice clinical study.During an ablation procedure to treat paroxysmal atrial fibrillation a polarsheath was selected for use.The polarsheath was prepped as recommended and inserted into the left atrium.It was reported that when the dilator was slowly removed, blood was leaking from the hemostatic valve.The sheath was exchanged and the procedure resumed.It was also reported that the related ep xt diagnostic catheter was kinked and the steer was not functioning appropriately after it was removed from the packaging.The physician attempted to use the catheter, however, the desired position was unable to be reached.The catheter was exchanged.The procedure resumed and was completed successfully without any patient complications.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

• Brand Name: POLARSHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 11607376
• MDR Text Key: 244853659
• Report Number: 2134265-2021-04243
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026195726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 04/30/2021
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 135