Catalog Number 1014651 |
Device Problems
Difficult to Remove (1528); Difficult to Advance (2920); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that the dragonfly opstar catheter met some resistance as it tracked over the wire during advancement to the lesion.It did reach the lesion.This was used with the optis mobile cart, aptivue.The physician reported the resistance felt was normal and what would be expected with a short rx catheter.It was not known if the resistance was with anatomy or the wire.The dragonfly reached the uncalcified lesion in the mid left anterior descending coronary artery.The physician purged the dragonfly but did not see contrast remove blood from the lens.There was no contrast leak noted at the syringe connection.Contrast was injected a couple of times but it did not trigger pullback to happen.An injection was seen down the vessel, but was not seen on the oct screen.No error message was displayed.When the physician went to remove the dragonfly, it became stuck on the wire.Both the dragonfly and the wire were removed together as a single unit.There was no visible damage to the dragonfly when it came out of the body.Ivus (intravascular ultrasound) was used to complete the procedure.Once outside the body, the dragonfly had to be forcefully pulled to get it off the wire.Outside the anatomy, the sales representative was able to perform a pullback and did not see any blood or abnormality in the lens region.The physician intentionally manipulated the dragonfly post procedure, resulting in visible tip damage and damage to the guide wire exit port.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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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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Manufacturer Narrative
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Visual and dimensional analysis was performed on the returned device.The reported difficulty removing the catheter, advancing the catheter, and activation failure were unable to be confirmed due to returned condition of the device and the operational context of the reported issues.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation determined that the difficulties advancing, difficulty removing the catheter, and activation/pullback failure were likely related to operational context.There were kinks noted to the returned catheter sheath as well as tearing to the guidewire exit notch which resulted in a separation of the distal tip, which is suggests there was difficulty positioning or withdrawing the catheter.It is likely that the observed condition and damage (kinks and torn guidewire exit notch) to the returned catheter contributed or caused the reported difficulty advancing and removing the catheter.The optical fiber of the returned device was revealed to have remained intact.There was one (1) successful pullback recorded on the returned device.The observed damage (torn sheath resulting in distal tip separation) was confirmed to have occurred after use, and during post-procedure handling.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Manufacturer Narrative
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Correction: d4 - primary udi number updated from 05415067031129 to: ((b)(4).
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Search Alerts/Recalls
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