Model Number M004CRBS3050 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2021 |
Event Type
malfunction
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Event Description
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It was reported that a polarsheath was selected for a paroxysmal atrial fibrillation cryoablation ablation procedure.During preparation prior to introduction into the patient, the doctor noticed that when aspirating from the side port, a lot of air was entering despite the tip of the polarsheath being immersed in a basin of water.The physician then decided to flash and aspirate, even trying to keep the valve close, but the problem returned.The sheath was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.
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Manufacturer Narrative
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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.
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Event Description
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It was reported that a polarsheath was selected for a paroxysmal atrial fibrillation cryoablation ablation procedure.During preparation prior to introduction into the patient, the doctor noticed that when aspirating from the side port, a lot of air was entering despite the tip of the polarsheath being immersed in a basin of water.The physician then decided to flash and aspirate, even trying to keep the valve close, but the problem returned.The sheath was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
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Manufacturer Narrative
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Visual inspection of the device showed there was an uncontrolled crater/tear on the surface of the outer slit there and leaks were observed.The sheath failed all standard manufacturing testing without any leak values in the pressure decay test; visible bubbles in the flush line during aspiration through various speeds; and dripping liquid leaks from the proximal end while pressurized at 5.5 psi in hemostasis testing.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).It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.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.
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Search Alerts/Recalls
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