Catalog Number H1-LS |
Device Problems
Contamination (1120); Use of Device Problem (1670)
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Patient Problems
No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
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Event Date 08/30/2019 |
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 attempted to use a h1-ls as per the ifu to treat a lesion in the sfa (superficial femoral artery).It was reported the physician performed an initial pass then removed it from the patient.Once reinserted another pass was attempted but there was an issue with it not disengaging all the way where it would not remove any material while running.The device was cleaned again and it was noted by the physician that he saw a "small black piece of something" when inspecting the tip.No patient injury reported.
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Manufacturer Narrative
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Product analysis: the device was received for evaluation.No ancillary device or images were received.The device was removed from the return packaging for visual inspection.The device was returned detached from the cutter driver.No biological debris was noted within the distal assembly.A slight bend was noted throughout the distal assembly.The bend began approximately 1.0 cm distal to the cutter window and continued toward the distal rotating tip.The distal rotating tip was bent in an ¿s¿ shaped curve.The cutter was returned advanced approximately 2.6cm distal to the cutter window.Microscopic inspection of the rotating distal tip did not reveal a black substance.A 0.014 guidewire from the lab was backloaded through the guidewire lumen to inspect for any debris within the lumen.The guidewire exited the lumen without resistance and a small piece of yellowish debris was observed exiting the lumen.Microscopic examination of the debris revealed it was biological in nature.The cutter driver was then connected to the hawkone and was activated.The cutter could be retracted; however, resistance was encountered.Inspection of the cutter revealed no anomalies.The cutter was then advanced approximately 1.8cm and resistance was encountered.The device was prevented from further advancement due to the observed bends in the distal assembly.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: the thumbswtich was able to be turned off.The cutter returned inside the housing for safe removal of the device from the patient.No deformation was noted in the cutter and no pieces were missing.No damage noted to tip.No pet liner delamination reported.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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