Catalog Number SGC01ST |
Device Problems
Leak/Splash (1354); Unstable (1667)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/28/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 the leak that occurred during preparation of the steerable guiding catheter.A leak has the potential to compromise the fluid path integrity and lead to an air embolism if the device were to be used in the anatomy.It was reported that during preparation of the steerable guide catheter (sgc), while flushing the dilator, the rotating hemostatic valve (rhv) failed during de-airing.When the valve was turned to close, while flushing forward, there was a backflow coming out the closed rhv.The rhv valve was not tight.The sgc was not used and there was no patient involvement.Another sgc was successful used in the case.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The steerable guiding catheter (sgc) was returned and device analysis confirmed the reported issue of a leak at the dilator rotating hemostasis valve (rhv) and unstable dilator cap.The dilator o-ring and silicone seal were misaligned and the silicone seal was noted to be compressed.A review of the lot history record revealed no non-conformances issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.Based on an expanded investigation, a product issue related to the observed leak and unstable dilator cap was noted.Further assessment of this issue per site operating procedures is being performed.Corrective and preventative actions are in the process of being implemented to address the issue per internal governing procedures.The performance of these devices will continue to be monitored.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of this report filed on the final mdr was inadvertently filed as 'na'; however, the correct date is (b)(4) 2015.(b)(4).
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Search Alerts/Recalls
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