Model Number M004CRBS3050 |
Device Problems
Difficult to Flush (1251); Device Contamination with Body Fluid (2317)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2020 |
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 the polarsheath were used in a polarx cryo-balloon procedure.It was noted that when the nurse first introduced the dilator inside the sheath, it was scraping and hard to introduce.The physician also said the balloon was more difficult to introduce than usual.Then on the last vein (right inferior pulmonary vein), they noticed that blood was coming backwards inside the tubing of the sheath.The pump used for flushing the sheath was not able to flush forward, saying that it faced an "occlusion".The procedure was completed with no complications being reported.
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Manufacturer Narrative
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Dimensional inspection of the device showed that the valve housing was inspected using gauge pins to assess the minor diameter.This location is the minimum pass through point for the dilator and polarx during clinical use.The inner diameter of the valve sheath housing was smaller than the passing manufacturing specification.There also appeared to be a material that was removed by inserting the gauge pins that were used to test the inner diameter.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
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Event Description
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It was reported that the polarsheath were used in a polarx cryo-balloon procedure.It was noted that when the nurse first introduced the dilator inside the sheath, it was scraping and hard to introduce.The physician also said the balloon was more difficult to introduce than usual.Then on the last vein (right inferior pulmonary vein), they noticed that blood was coming backwards inside the tubing of the sheath.The pump used for flushing the sheath was not able to flush forward, saying that it faced an "occlusion".The procedure was completed with no complications being reported.
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Search Alerts/Recalls
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