Catalog Number SGC0301 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number (b)(4).The device will not be returned for evaluation, the device was reportedly retained by the hospital.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 is being filed to report the leak in the steerable guide catheter during preparation.It was reported that during preparation of the steerable guide catheter (sgc), column was lost therefore the device was not used.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
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Manufacturer Narrative
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Exemption number e2019001.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 identified no similar incidents reported from this lot.All available information was investigated and a definitive cause for the reported sgc leak (loss of fluid column during sgc preparation) could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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