Model Number 29462 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/17/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device was fractured.A 180cm/135cm renegade hi-flo fathom system was selected for use.Upon unpacking, it was noted that the device was fractured.The procedure was completed with another of the same device.There were no complications reported and the 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 three kinks located 9.5cm,46cm and 126cm from the hub.No fracture was noticed.Inspection of the remainder of the device apart from the observed damage, revealed no other damage or irregularities.
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Event Description
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It was reported that the device was fractured.A 180cm/135cm renegade hi-flo fathom system was selected for use.Upon unpacking, it was noted that the device was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.
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Search Alerts/Recalls
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