Model Number 44021 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2024 |
Event Type
malfunction
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Event Description
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It was reported that a catheter issue occurred.Vascular access was obtained via an ipsilateral antegrade approach.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, a catheter twist occurred when a pressing operation was performed for the chronic total occluded lesion.The procedure was completed with a different device.There were no patient complications reported.
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Manufacturer Narrative
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D2b: pro code (product code): corrected.
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Event Description
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It was reported that a catheter issue occurred.Vascular access was obtained via an ipsilateral antegrade approach.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, a catheter twist occurred when a pressing operation was performed for the chronic total occluded lesion.The procedure was completed with a different device.There were no patient complications reported.
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Manufacturer Narrative
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The device was returned for analysis.Visual and microscope inspections revealed the imaging window was twisted.Media returned by the customer was inspected and showed the catheter was twisted.Based on the evidence, the as reported code of catheter material twisted can be confirmed.
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Event Description
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It was reported that a catheter issue occurred.Vascular access was obtained via an ipsilateral antegrade approach.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, a catheter twist occurred when a pressing operation was performed for the chronic total occluded lesion.The procedure was completed with a different device.There were no patient complications reported.
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Search Alerts/Recalls
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