Model Number SGC0701 |
Device Problems
Difficult to Flush (1251); Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2022 |
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.Na.
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Event Description
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This will be filed to report the difficulty flushing the device.It was reported that during preparation of the dilator, it could not be flushed.An attempt was made to advance a guide wire through the dilator however it could not pass through the rotating hemostatic valve (rhv).The device was not used and replaced with a new one.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
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Manufacturer Narrative
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The returned device analysis confirmed the reported difficult to flush & difficult to insert.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.Based on the available information and return device analysis the investigation determined that reported difficult to flush & difficult to insert are cascading effects of the observed dilator blockage.The observed blockage in the dilator 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.
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Search Alerts/Recalls
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