Catalog Number 22443-19 |
Device Problems
Off-Label Use (1494); Difficult to Remove (1528)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/31/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device was returned for analysis.The reported difficulty to remove the barewire could not be confirmed as the exact conditions encountered by the device during the procedure could not be replicated in a testing environment as it was based on operational circumstances.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.Reportedly, the emboshield nav6 eps was being used to treat a lesion in the calcified distal femoral artery, it should be noted that the emboshield nav 6 instruction for use states: the emboshield nav6 rapid exchange (rx) embolic protection system is a temporary percutaneous transluminal filtration system designed to be used as a guide wire and to capture embolic material released during an angioplasty and stent procedure within a saphenous vein bypass graft or a carotid artery.In this case, it is unknown if the reported ifu violation contributed to the reported difficulties.Based on the information provided, the difficulty removing, and subsequent stretched tip coils and break were likely due to circumstances of the procedure.In this case, it is likely that clearance between the inner diameter of the jetstream device and outer diameter of the barewire became reduced during use resulting in the devices becoming stuck together causing difficulty to remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The barewire device referenced is filed under a separate medwatch report.
|
|
Event Description
|
It was reported that the atherectomy procedure was to treat a mildly tortuous, heavily calcified distal femoral in-stent stenosis.The emboshield nav6 barewire was exchanged for a longer barewire to be used.The barewire was advanced to the target lesion and the procedure was completed.At the end of the procedure, when a non-abbott atherectomy device was being removed, it met resistance with the barewire.Once the barewire was removed, it was noted to be damaged badly at the distal end (unraveled, stretched).It was confirmed there were no issues with the use of the emboshield nav6 device.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information from the account and device analysis confirmed: [when removing the jetstream there was a resistance with the barewire.When attempting to remove the filter and retrieval catheter over the bare wire, it was unable to do so, therefore the barewire was removed altogether with the filter and retrieval catheter as one as device analysis noted the devices were returned frozen together.No additional information was provided.
|
|
Search Alerts/Recalls
|
|