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Model Number 2077-01 |
Device Problems
Difficult to Remove (1528); Stretched (1601); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Event Description
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It was reported guidewire removal difficulty occurred.A rotawire drive guidewire was selected for percutaneous coronary intervention (pci).The 92% stenosed, moderately tortuous and severely calcified target lesion was located in circum flexa.During the procedure, it was noted that the rotawire kinked at the end of the radiopaque part with very calcified vessels.Difficulty was noted when retrieving rotawire as it was extremely elongated by the inner core, eventually rotawire was completely removed.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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B3: as the event date was not reported, the first day in the month of the aware date is provided.
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Manufacturer Narrative
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B3: as the event date was not reported, the first day in the month of the aware date is provided.B5 describe event or problem: updated.Device media analysis: the media attached to the complaint shows a kinked, bent and elongated guidewire.This could be related to the reported issues of "distal end kinked, guidewire difficult to remove".
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Event Description
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It was reported guidewire removal difficulty occurred.A rotawire drive guidewire was selected for percutaneous coronary intervention (pci).During the procedure, it was noted that the rotawire kinked at the end of the radiopaque part with very calcified vessels.Difficulty was noted when retrieving rotawire as it was extremely elongated by the inner core, eventually rotawire was completely removed.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that 92% stenosed, moderately tortuous and severely calcified target lesion was located in circum flexa.
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Search Alerts/Recalls
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