Model Number M004CRBS3050 |
Device Problems
Leak/Splash (1354); Material Integrity Problem (2978)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/25/2021 |
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.To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device.On april 13, 2021, boston scientific issued a field safety notice (92688876-fa) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.
|
|
Event Description
|
It was reported that during a procedure involving a polarsheath device the cap on back of the handle detached.When a balloon catheter that was inserted though the polarsheath was removed, the valve of the sheath began to leak.The polarsheath could not be used to continue with rf (radiofrequency) ablation.No patient complications were reported.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
|
|
Manufacturer Narrative
|
To reduce the potential for air ingress into the sheath and the risk of embolism, the polarsheath instructions for use (ifu) was revised to emphasize best practices during use of this device.On april 13, 2021, boston scientific issued a field safety notice (92688876-fa) to communicate these ifu updates to all global customers in the interest of minimizing the risk of air embolism and promoting consistent use of the ifu in all geographies.Device technical analysis visual inspection of the device showed the end cap of the sheath was detached and not returned with device.There were no obvious tears/punctures appearing on the outer slit of the hemostatic.The device passed both the normal and extensive engineering aspiration and hemostasis testing.The device also passed the air pressure test for leaks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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.
|
|
Event Description
|
It was reported that during a procedure involving a polahsheath device the cap on back of the handle detached.When a balloon catheter that was inserted though the polarsheath was removed, the valve of the sheath began to leak.The polarsheath could not be used to continue with rf (radiofrequency) ablation.No patient complications were reported.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
|
|
Search Alerts/Recalls
|