Model Number M004CRBS3050 |
Device Problem
Difficult to Flush (1251)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2021 |
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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During a cryoablation procedure a polarsheath was selected for use.It was reported hat irrigation of the sheath stopped when the sheath was pushed towards the balloon.The inability to flush was only observed on the irrigation set, however, it occurred with and without freezing.Irrigation was possible again when the sheath was pulled backwards.No patient complications were reported.
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Manufacturer Narrative
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The device was returned to boston scientific for analysis.Visual inspection did not find any physical abnormalities.A polarx balloon catheter within allowable tolerance was used for testing.There were no issues observed while inserting catheter through sheath.Pump was active at 30 ml/min for all flow testing to ensure maximum amount of flow was eligible for implementation.The catheter was placed in the distal tip, middle and valve housing regions of the sheath shaft while flow was active.The irrigation passed without any emerging issues.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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During a cryoablation procedure a polarsheath was selected for use.It was reported hat irrigation of the sheath stopped when the sheath was pushed towards the balloon.The inability to flush was only observed on the irrigation set, however, it occurred with and without freezing.Irrigation was possible again when the sheath was pulled backwards.No patient complications were reported.
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Search Alerts/Recalls
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