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.
|
|
Search Alerts/Recalls
|