Catalog Number SGC0705 |
Device Problems
Material Separation (1562); Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported the device is not returning.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 detachment.It was reported during preparation of the steerable guide catheter (sgc), the dilator was flushed; however, the hemostatic valve became separated from the sgc which led to the hemostatic valve could no longer be rotated.The sgc was not used in the patient and the procedure was successfully completed with a new sgc.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for 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 complaints reported from this lot.The investigation determined the reported rhv detachment appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.D4: part number, expiration date and udi was updated
h6: device code 2983 was removed.
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Event Description
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N/a.
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Search Alerts/Recalls
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