Model Number 29462 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
malfunction
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Event Description
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It was reported that there was irregular hairiness.A 180cm/135cm renegade hi-flo fathom system was selected for use.During the procedure, it was noted that there was irregular hairiness at the tip of the microcatheter when it was flushed.The procedure was completed with another of the same device.There were no complications reported and patient was stable post procedure.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The device returned with a guidewire in the lumen.The device was inspected for any damage or irregularities.The renegade shaft and tip were microscopically examined for any foreign material present.There was no indication of any foreign material on the shaft or tip.The renegade showed damage in the form of flattened areas along the distal part of the shaft located 126cm from the hub to the tip.The renegade showed a coating build up approximately 125cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint for foreign material was not confirmed; however, shaft damage was confirmed.
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Event Description
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It was reported that there was irregular hairiness.A 180cm/135cm renegade hi-flo fathom system was selected for use.During the procedure, it was noted that there was irregular hairiness at the tip of the microcatheter when it was flushed.The procedure was completed with another of the same device.There were no complications reported and patient was stable post procedure.
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Search Alerts/Recalls
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