Model Number 29462 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/19/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device was detached.A 180cm/135cm renegade hi-flo fathom system was selected for use.Upon unpacking, the device was found detached when flushed.The procedure was completed with another of the same device.There were no complications reported and patient was stable.
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Event Description
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It was reported that the device was detached.A 180cm/135cm renegade hi-flo fathom system was selected for use.Upon unpacking, the device was found detached when flushed.The procedure was completed with another of the same device.There were no complications reported and patient was stable.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for evaluation.The hub, shaft and tip were microscopically examined.The device showed a stretched area located 49cm from the hub.No fracture was noticed.Multiple kinks were noticed from the tip to proximal 12.5cm.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.
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Search Alerts/Recalls
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