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Catalog Number H1-M |
Device Problems
Defective Component (2292); Difficult to Open or Close (2921); Mechanical Jam (2983)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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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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It was reported that the physician attempted to use a h1-m to treat a lesion in the superficial femoral artery(sfa) as per the ifu.No abnormalities were reported in relation to the patient anatomy.It was reported the thumbswitch on the hawkone device jammed while in use in the patient and would not fully close or open.The device was removed safely from the patient.The device was cleaned but remained stuck.The thumbswitch would not push all the way forward or back, so tissue could not be completely flushed.The customer verified the nosecone was not full.No deformation was noted to the cutter and no pieces of the cutter were reported to be missing the procedure was completed prior to the hawkone thumbswitch malfunction.It was post-dilated with pta.No cine images are available.No patient injury was reported.
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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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Search Alerts/Recalls
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