Catalog Number SGC0302 |
Device Problems
Difficult to Insert (1316); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The steerable guide catheter was received.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 report is filed for the tear noted on the soft tip of the steerable guide catheter.A torn soft tip has the remote potential to cause serious injury if a piece of the soft tip is left behind in the anatomy.It was reported that during a mitraclip procedure, the steerable guide catheter (sgc) was unable to be inserted into the femoral vein.The femoral vein was dilated again; however, the sgc soft tip had been damaged and ripped.Another sgc was used in replacement without reported issue.There were no adverse patient effects and there was no clinically significant delay.Two mitraclips were implanted and functional mitral regurgitation was reduced from grade 4 to grade 1.There was no additional information provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device returned for analysis and the reported steerable guide catheter (sgc) torn soft tip was not confirmed, but was noted to be damaged (kinked).The reported failure to advance was unable to be tested as it related to the anatomy.A review of the lot history record revealed no manufacturing nonconformities.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and the reported failure to advance resulting in the soft tip damage appears to be related to user technique/procedural conditions.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 medwatch report, the additional information was received: the steerable guide catheter (sgc) was unable to insert into the vena cava.Reportedly, a lot of push was required; however the sgc soft tip had then become damaged and ripped.
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Search Alerts/Recalls
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