Catalog Number SGC0301 |
Device Problems
Break (1069); Difficult to Insert (1316); 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 01/09/2018 |
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 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 event is filed for a cable break.It was reported that the patient, with degenerative mitral regurgitation (mr), underwent a mitraclip procedure.The steerable guide catheter (sgc) was prepared for use and no issues were noted.The sgc minus knob was turned a half turn to straighten the device; however, difficulty was noted during insertion into the patient anatomy.An additional half turn was made, 1 full turn.A noise was heard and the minus cable broke.The device was not used and a new sgc was prepared.The second sgc was inserted into the patient anatomy without difficulty and two clips were implanted, reducing the mr from grade 3+ to grade 1.There was no additional information provided.
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Manufacturer Narrative
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(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 difficult to insert and cable break could not be determined.The reported device operating differently than expected (noise) appears to be related to the cable break.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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