Model Number 29462 |
Device Problems
Break (1069); Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/29/2020 |
Event Type
malfunction
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Event Description
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It was reported that the microcatheter was fractured.A renegade hi-flo fathom system was selected for use.After opening the sterile packaging, removal of the microcatheter was difficult and upon removal, it was noted that the catheter became separated into two pieces.Another catheter was used successfully.The device was not used on the patient.The procedure was completed with another of the same device.No patient complications were reported.
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Event Description
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It was reported that the microcatheter was fractured.A renegade hi-flo fathom system was selected for use.After opening the sterile packaging, removal of the microcatheter was difficult and upon removal, it was noted that the catheter became separated into two pieces.Another catheter was used successfully.The device was not used on the patient.The procedure was completed with another of the same device.No patient complications were reported.
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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 renegade hi-flo fathom system was selected for use.After opening the sterile packaging, removal of the microcatheter was difficult and upon removal, it was noted that the catheter became separated into two pieces.Another catheter was used successfully.The device was not used on the patient.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed a fracture in the outer shaft located 5mm from the strain relief, outer shaft damage (stretched) for 16mm, and the inner shaft was stretched between the outer shaft fracture faces.Inspection of the rest of the device found no other damage or defect.
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Search Alerts/Recalls
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