Model Number M004CRBS3050 |
Device Problems
Leak/Splash (1354); Device Contamination with Body Fluid (2317)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2021 |
Event Type
malfunction
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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 used in a pulmonary vein isolation (pvi) polarx cryoablation procedure.It was noted that when the sheath was inserted into the patients left atrium (la) while the physician aspirated the leaked blood from the sheaths sideport.The sheath was replaced and the procedure was completed with no patient complications.
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Event Description
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It was reported that a polarsheath was used in a pulmonary vein isolation (pvi) polarx cryoablation procedure.It was noted that when the sheath was inserted into the patients left atrium (la) while the physician aspirated the leaked blood from the sheaths sideport.The sheath was replaced and the procedure was completed with no patient complications.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 no major abnormalities found.During functional testing the device passed all standard the aspiration, hemostasis, and air pressure tests.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).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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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