Model Number 44021 |
Device Problems
Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device became stuck on the guidewire.The 99% stenosed target lesion was mildly tortuous and severely calcified.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.While inside the patient, the opticross catheter became stuck on the guidewire.The physician was able to remove both the catheter and guidewire together as a unit.Another of the same device was used to successfully complete the procedure.There were no patient complications.
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Manufacturer Narrative
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The device was returned for analysis.Visual and microscope inspection revealed the imaging window was twisted at the lap joint section, and at 7.5 cm from the lap joint section.Microscope inspection also revealed the guidewire exit port was damaged, but the tip was in good condition.
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Event Description
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It was reported that the device became stuck on the guidewire.The 99% stenosed target lesion was mildly tortuous and severely calcified.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.While inside the patient, the opticross catheter became stuck on the guidewire.The physician was able to remove both the catheter and guidewire together as a unit.Another of the same device was used to successfully complete the procedure.There were no patient complications.
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Event Description
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It was reported that the device became stuck on the guidewire.The 99% stenosed target lesion was mildly tortuous and severely calcified.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.While inside the patient, the opticross catheter became stuck on the guidewire.The physician was able to remove both the catheter and guidewire together as a unit.Another of the same device was used to successfully complete the procedure.There were no patient complications.
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Manufacturer Narrative
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D2b: pro code (product code) : corrected.The device was returned for analysis.Visual and microscope inspection revealed the imaging window was twisted at the lap joint section, and at 7.5 cm from the lap joint section.Microscope inspection also revealed the guidewire exit port was damaged, but the tip was in good condition.
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Search Alerts/Recalls
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