Model Number 29460 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that the tip of the device was fractured.The target lesion was located in the liver vessel.A 35/10 renegade hi flo was selected for use.During the preparation, it was noted that the tip of device was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
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Manufacturer Narrative
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E1.Initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The hub and shaft were visually inspected when returned.The renegade device showed no tip damage; however, there was a kink located 134.5cm from the hub as well as a damaged/flattened shaft located at the hub to 120cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no damage or irregularities.The complaint was not confirmed for a tip fracture; however, shaft damage was confirmed.
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Event Description
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It was reported that the tip of the device was fractured.The target lesion was located in the liver vessel.A 35/10 renegade hi flo was selected for use.During the preparation, it was noted that the tip of device was fractured.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
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Search Alerts/Recalls
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