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 08/03/2021 |
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 atrial fibrillation ablation procedure.It was noted that during insertion into the patient the valve had a leakage.The polarsheath was exchanged and the procedure was completed successfully with no patient complications.
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Manufacturer Narrative
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Visual inspection of the device showed no visual defects with some liquid in flush line and some blood on the shaft.The device passed all standard aspiration, hemostasis, and air pressure testing.There is no evidence this device was used in a manner inconsistent with the labeled indications.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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Event Description
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It was reported that a polarsheath was used in a atrial fibrillation ablation procedure.It was noted that during insertion into the patient the valve had a leakage.The polarsheath was exchanged and the procedure was completed successfully with no patient complications.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.
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Search Alerts/Recalls
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