Model Number 29420 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/22/2020 |
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 microcatheter was fractured.A 135/10 renegade hi-flo kit was selected for use in an embolization of hepatic hemangioma.During the procedure, when the physician unpacked the package and after sufficient flushing was done, it was noted that the microcatheter was fractured when it was removed from the carrier hoop.The device did not enter the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.
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Manufacturer Narrative
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E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for analysis.The device was inspected for any damage or irregularities.The renegade showed damage in the form of a slight stretching and a fracture of the shaft.The fracture was located 2.5cm from the hub.The device was not completely separated, the inner liner was still attached.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 microcatheter was fractured.A 135/10 renegade hi-flo kit was selected for use in an embolization of hepatic hemangioma.During the procedure, when the physician unpacked the package and after sufficient flushing was done, it was noted that the microcatheter was fractured when it was removed from the carrier hoop.The device did not enter the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.
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Search Alerts/Recalls
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