Catalog Number SGC0302 |
Device Problems
Break (1069); Positioning Failure (1158); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional device listed is filed under a separate medwatch report.
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Event Description
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This is filed to capture the device unable to straighten.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.During preparation of the clip delivery system (cds) (91008u183), the grippers did not lower to 120 degrees.Troubleshooting was performed, but the issue was unable to be resolved.The cds was not used and was replaced.Two clips were successfully implanted reducing mr to a grade of 2; however, when the steerable guide catheter (sgc) (91101u123) was removed from the femoral vein, the +/- knob was not functioning.It was noted that the sgc function as intended during the procedure.However, when the sgc was removed, it was noticed that the sgc was unable to be straightened.A cable break was also suspected.The sgc was then tested outside the anatomy and the - knob continued to not work.No additional devices were used in the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Subsequent to the initially filed report, the following information was received: the minus knob of the steerable guide catheter could only be turned up to about 270 degrees during preparation and the procedure.
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Manufacturer Narrative
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All available information was investigated and the reported cable break and unable to straighten the steerable guide catheter (sgc) were confirmed via returned device analysis.The reported unable to curve and mechanical jam of the knob was not confirmed.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 complaints reported from this lot.The investigation determined the reported inability to straighten the sgc appears to be related to ¿-¿ cable break.However, a conclusive cause for the cable break, knob jam and inability to curve the sgc cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.H6: code 2983 added.
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Search Alerts/Recalls
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