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Model Number GW1420040 |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Event Description
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As reported: web procedure, after establishing the pathway, guidewire with via to the m2 in the brain, carried out superselection into the aneurysm, after several times without success, ready to remove and remodel.After the removed, the physician found that the clean water coating on the surface of the guide wire fell and replaced it with a new one.The procedure ended and the patient was safely.Patient is fine.
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Manufacturer Narrative
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The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
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Manufacturer Narrative
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Section b5: additional information received.Section h6 (type of investigation): code has been corrected from "device discarded" to "device not returned".The device is in transit to be returned to the manufacturer for evaluation but has not yet been received by the manufacturer.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
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Event Description
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As reported: during the web procedure, after establishing the pathway, guidewire with via to the m2 in the brain, superselection was carried out into the aneurysm.After several times without success, the physician was ready to remove and remodel.After removal, the physician found that the clean water coating on the surface on the guidewire fell and replaced with it with a new one.The procedure ended and the patient was safe.Additional information received: when the doctor took out the micro-guidewire outside the patient's body and reshaped it, he found that the coating fell (to his finger).The physician confirmed that no fallen coating was in the patient's body.
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Search Alerts/Recalls
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