Catalog Number 1014652 |
Device Problems
Break (1069); 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 12/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Event Description
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It was reported the distal part of the dragonfly opstar imaging catheter was found to be broken and could not be placed.Its unknown at this time how the procedure was completed.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Event Description
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Subsequent to the initially filed medwatch report, additional information was received.It was reported the distal part of the dragonfly opstar imaging catheter was kinked therefore it could not be placed in the lesion.The procedure was completed without using imaging.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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Visual inspection was performed on the returned device.The reported deformation was confirmed.Visual examination revealed kinks near the distal end of the device.Additionally, the rfid (radio frequency identification device) revealed the catheter had performed two (2) pullbacks.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 did not indicate a lot specific quality issue.The investigation determined that the reported deformation was related to circumstances of the procedure.Based on the information provided and analysis of the returned device, it is likely that the device was inadvertently damaged/kinked during preparation/use resulting in the noted kinks.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 1069 was removed and code 2889 was added.
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Search Alerts/Recalls
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