Model Number P4044 |
Device Problems
Misfire (2532); Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/06/2020 |
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 intended to use a silverhawk device with a 6fr sheath and non-medtronic guidewire during treatment of a plaque cto (chronic total occlusion-100%) in the patient¿s mid and distal popliteal artery and anterior tibial artery.No vessel tortuosity or calcification reported.Ifu was followed.Vessel pre-dilation was not performed.It is reported the device did not engage with the plaque.The device was safely removed from the patient.It is unknown about the position of the blade relative to the housing during removal of the device.There was no deformation noted in the cutter.The device was replaced with another atherectomy device to complete the procedure.There was no vessel damage noted.No patient injury reported.
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Manufacturer Narrative
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Product analysis: the silverhawk was returned inside a biohazard bag with a device label attached which indicated lot 0009882970.The silverhawk was inspected.The cutter was located within the cutter window.Dried blood was observed behind and in front of the cutter.The coiled housing showed a gradual bend at approximately 1cm distal the cutter window.No damages were noted to the silverhawk drive shaft or thumb switch assembly.The silverhawk was attached to a cutter driver from the lab.With the cutter driver activated the cutter could not advance within the housing.The distal assembly was soaked in water and the cutter was unable to advance.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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