Model Number C408646 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2022 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was performed in the left circumflex (lcx) coronary artery with moderate calcification and tortuosity.The dragonfly catheter was advanced into the target lesion, but became stuck short of the lesion due to the angulation and a kink occurred.There was no error message.Another device was used instead, the procedure was completed with no adverse patient effect.The physician thought the issue was due to the patient's anatomy.No additional information was provided.
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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Subsequent to the previously filed report, additional information was received that he dragonfly catheter could not cross the lesion.There was no difficulty when removing the dragonfly catheter.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no indication of a lot specific product quality issue.Based on the information provided and analysis of the returned device, the reported failure to advance and catheter damage (catheter sheath kinked) is likely related to/due operational context.It may be possible that patient anatomical morphology or handling caused the observed kink which affected device maneuverability; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 1528 removed.
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Search Alerts/Recalls
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