Model Number SGC0301 |
Device Problems
Product Quality Problem (1506); Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device 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 is filed to report torn material.It was reported that during preparation, the distal end of the steerable guide catheter (sgc) felt bumpy.It was then noticed that the flush basin seemed to contain a foreign object, which was potentially some of the hydrophilic coating on the tip of the sgc.The sgc was not used and replaced.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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All available information was investigated and the reported issues of product quality problem-irregular texture on the distal end and hydrophilic coating tip tear 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 complaint.Additionally, a review of the complaint history identified no similar incidents for this lot.Based on the information reviewed, a cause for the reported bumpiness on distal end (irregular texture) and potential hydrophilic coating tip tear could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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