Lot Number 0029181382 |
Device Problems
Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that a foreign material was found on the device.A 2.75 x 24mm synergy xd drug-eluting stent was selected for use.However, during preparation, a foreign object was noted at the hub and due to this object, the inflation device could not be connected to the hub.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
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Event Description
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It was reported that a foreign material was found on the device.A 2.75 x 24mm synergy xd drug-eluting stent was selected for use.However, during preparation, a foreign object was noted at the hub and due to this object, the inflation device could not be connected to the hub.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
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Manufacturer Narrative
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Returned product consisted of a synergy xd drug eluting stent.A visual, tactile and microscopic examination of the returned device was performed.A detailed examination of the hub manifold identified that the manifold was plugged with a piece of plastic, consistent with the tip of a syringe.It was not possible to remove this from the hub.No damage was observed to actual hub.No damage was observed along the balloon.The stent was fully crimped onto the balloon.No other damage was observed along the device.
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Search Alerts/Recalls
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