Model Number SGC0301 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported the device was discarded and is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Event Description
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This report is filed as the steerable guide catheter was unable to hold fluid column during preparation.It was reported that the steerable guide catheter was being prepped per instructions for use when the fluid column was unable to hold.There were no other device issues observed, however, after 4 attempts testing the fluid column, the fluid column was unable to hold.There was no patient involvement and the device was discarded.No additional information was provided regarding this device issue.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the loss of fluid column.There is no indication of a product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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