Catalog Number SGC0301 |
Device Problems
Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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This is filed to report the inability to deflect the steerable guide catheter (sgc) tip.It was reported that during device preparation, when turning the negative knob an audible click was heard, after which negative was no longer responding.A new sgc was prepped and used without issue.There was no patient involvement or a clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and a definitive cause for the reported mechanical issue of loss of tip deflection and noise could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
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Search Alerts/Recalls
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