|
Lot Number 0029927876 |
Device Problems
Use of Device Problem (1670); Air/Gas in Device (4062)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/11/2022 |
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 air was drawn in from the side port of the sheath.During a myocardial ablation procedure to treat atrial fibrillation, a polarsheath steerable sheath was selected for use.When a syringe was connected to the side port of the sheath and the balloon catheter was inserted while drawing back blood, air was drawn in from the side port.The sheath tip was blocked due to the lack of space between the outer diameter of the balloon catheter and the inner diameter of the sheath, and air was drawn in from the hemostatic valve side, which is suspected to have caused the problem.Suction was applied through the side port to allow aspiration.The procedure was completed using the sheath.The procedure was completed using the sheath.No patient complications were reported.The device is expected to be returned for analysis.
|
|
Manufacturer Narrative
|
The polarsheath was returned to boston scientific for laboratory analysis.A visual inspection was performed, and no abnormalities were observed.A functional test was performed that included an aspiration test, a hemostasis valve test, and air pressure test.The sheath passed all standard manufacturing testing.The sheath was able to hold pressure while pressurized at 5.5 psi in hemostasis testing.Laboratory analysis was unable to confirm the reported clinical observation.
|
|
Event Description
|
It was reported that air was drawn in from the side port of the sheath.During a myocardial ablation procedure to treat atrial fibrillation, a polarsheath steerable sheath was selected for use.When a syringe was connected to the side port of the sheath and the balloon catheter was inserted while drawing back blood, air was drawn in from the side port.The sheath tip was blocked due to the lack of space between the outer diameter of the balloon catheter and the inner diameter of the sheath, and air was drawn in from the hemostatic valve side, which is suspected to have caused the problem.Suction was applied through the side port to allow aspiration.The procedure was completed using the sheath.The procedure was completed using the sheath.No patient complications were reported.The device has been returned for analysis.
|
|
Search Alerts/Recalls
|
|
|