Model Number 1973-03 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that the catheter was stuck on the guidewire.A 4.0 x 200mm, 150cm ranger drug-coated balloon was selected for use.The stenosed target lesion was located in the mildly tortuous and moderately calcified popliteal artery.During the procedure, when the physician tried to advance the ranger over the guide wire, it got stuck into the shaft.The device was removed from the patient and the procedure was completed with another of the same device.There were no patient complications.
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Manufacturer Narrative
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Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device was tracked over a test 0.018" guidewire and it was able to pass through.Inspection of the remainder of the device presented no damage or irregularities.Product analysis could not confirm the reported froze on wire and found no damage that would have contributed to the reported event.
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Event Description
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It was reported that the catheter was stuck on the guidewire.A 4.0 x 200mm, 150cm ranger drug-coated balloon was selected for use.The stenosed target lesion was located in the mildly tortuous and moderately calcified popliteal artery.During the procedure, when the physician tried to advance the ranger over the guide wire, it got stuck into the shaft.The device was removed from the patient and the procedure was completed with another of the same device.There were no patient complications.
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Search Alerts/Recalls
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