Model Number FRED2508-PMA |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and was not returned to the manufacturer; therefore, the alleged product issue cannot be confirmed.
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Event Description
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It was reported that after deployment of the fred, the delivery wire became caught on the stent during retraction.The delivery wire released from the fred with additional manipulation of the wire.There was no reported patient injury or intervention.The patient is reported to be "fine.".
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Search Alerts/Recalls
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