Catalog Number SGC0301 |
Device Problems
Positioning Failure (1158); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/24/2019 |
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 straighten the steerable guide catheter (sgc) tip.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The sgc was inserted into the anatomy.When rotating the +/- knob in the minus direction, a pop sound was heard, and the sgc tip would not straighten.The sgc was removed and replaced with a new sgc.Two clips were implanted, reducing mr to 2.There were no adverse patient effects and no 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 revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.A definitive cause for a reported unable to straighten the steerable guide catheter (sgc) could not be determined in this incident.Additionally, the reported noise appears to be a cascading effect of mechanical issue.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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