Model Number 29460 |
Device Problems
Break (1069); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2021 |
Event Type
malfunction
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Event Description
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It was reported that the microcatheter fractured.A renegade hi flo infusion catheter was selected for use in the main hepatic artery.The renegade catheter was used along with a 0.018 transcend guidewire.During the advancement of the renegade catheter into the distal hepatic artery, despite multiple attempts, the catheter could not be advanced to the intended location.The physician withdrew the catheter and found that the renegade infusion catheter fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post-procedure.
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Event Description
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It was reported that the microcatheter fractured.A renegade hi flo infusion catheter was selected for use in the main hepatic artery.The renegade catheter was used along with a 0.018 transcend guidewire.During the advancement of the renegade catheter into the distal hepatic artery, despite multiple attempts, the catheter could not be advanced to the intended location.The physician withdrew the catheter and found that the renegade infusion catheter fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post-procedure.
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Manufacturer Narrative
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Device evaluated by manufacturer: the renegade showed damage in the form of a fracture located 23cm from the hub.The device was not completely separated the inner liner was still intact.There was severe stretching located 55.5cm to 66.5cm from the hub.No other damage was noticed.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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