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Catalog Number SGC0702 |
Device Problems
Break (1069); Unstable (1667); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 filed to report a cable break.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (dmr) with grade 3-4.The steerable guide catheter (sgc) was inserted in the femoral vein, a half turn of the minus knob was used.After the sgc had been inserted, more minus knob was applied but a cracking sound was heard from the minus knob.The sgc was in the septum and the physician attempted to release some of the minus knob applied, however it was no longer possible.When using the minus knob, the sgc stretched and the knob rotated freely.The physician suspected a cable break.The sgc was removed from the patient and a new sgc was used to successfully complete the procedure.The procedure was completed with one mitraclip implanted.The mr was reduced to grade 1+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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All available information was investigated, and the reported noise, knob instability and cable break could not be confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on available information, a cause of the speculated cable break could not be determined.The cause of the reported popping noise and knob instability also could not be determined.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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N/a.
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Search Alerts/Recalls
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