Model Number 44021 |
Device Problems
Entrapment of Device (1212); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/28/2019 |
Event Type
malfunction
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Event Description
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It was reported that catheter entanglement on the guidewire occurred.The 99% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.After passing through the guidewire, the device was delivered.There was resistance noted when crossing the lesion.When the imaging was performed it was observed under fluoroscopy that there was entanglement between the guidewire and this ivus device.The guidewire was carefully removed and the procedure was continued re-using it again.There were no patient complications that were reported.
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Event Description
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It was reported that catheter entanglement on the guidewire occurred.The 99% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.After passing through the guidewire, the device was delivered.There was resistance noted when crossing the lesion.When the imaging was performed it was observed under fluoroscopy that there was entanglement between the guidewire and this ivus device.The guidewire was carefully removed and the procedure was continued re-using it again.There were no patient complications that were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the catheter was received without the distal tip assembly.Device analysis revealed multiple kinks in the sheath assembly in the distal end.The guidewire test can't be performed snince the distal tip was not received.
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Search Alerts/Recalls
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