Catalog Number SGC0302 |
Device Problems
Material Separation (1562); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/11/2018 |
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 device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The clip delivery system referenced is filed under a separate medwatch report.
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Event Description
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This is filed to report the steerable guide catheter(sgc) soft tip tear.It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr), with an mr grade of 3-4.The steerable sgc and clip delivery system (cds) were advanced to the left atrium.During positioning of the cds, when the m-knob was applied, the cds went in the opposite direction.The cds was retracted, but the clip became caught on the tip of the sgc.Troubleshooting was performed and ultimately, the clip successfully removed from the sgc.It was noted that a portion of the sgc tip was in the clip.The cds was retracted into the sgc and removed with the clip.The sgc was removed and replaced.A new cds was used without issue.Two clips were implanted, reducing the mr to 1+.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).All available information was investigated and the reported detached soft tip was 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 incidents reported from this lot.All available information was investigated, and the detachment of the soft tip in this incident appears to be related to the user technique/procedural circumstances of the clip becoming caught on the guide soft tip during removal.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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Subsequent to the initial report, the photo provided was reviewed and it appears that the entire steerable guide catheter (sgc) soft tip detached from the sgc and was caught in the clip.No additional information was provided.
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Search Alerts/Recalls
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