Catalog Number H1-M |
Device Problems
Failure to Power Up (1476); Device Remains Activated (1525); Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician was attempting to use a hawkone to treat plaque in the proximal superficial femoral artery physician used a non-medtronic 6fr sheath and 0.014 non medtronic guidewire.Ifu was followed and the device was prepped without issue.It was reported that during the procedure the device was advanced into sheath.When attempt was made to engage cutter, it was noted that device would not turn on.Device was removed intact and a fracture was noticed just distal to the cutter.The blade did not return to the housing after removal and remained in a open cutting position.The procedure was completed using a new device.No patient injury reported.
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Manufacturer Narrative
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Device evaluation: the hawkone was received still attached to its cutter driver unit.The distal assembly was received torsional damage just distal of the cutter window, with the tecothane coating also damaged.The cutter head remains within the distal coil section of the distal assembly.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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