Model Number M0035421030 |
Device Problems
Fracture (1260); Expulsion (2933)
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Patient Problem
Occlusion (1984)
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Event Date 03/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available to the manufacturer.
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Event Description
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It was reported that the coil (subject device) experienced difficulty advancing from the distal tip of the microcatheter and had fractured during use.Upon attempt of removal of microcatheter appeared to be protruded and occluded the vessel.The microcatheter was removed and the physician replaced the microcatheter and used a stent to adjust the protruded coil to return blood flow.The procedure completed without clinical consequences to the patient.
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Manufacturer Narrative
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It was confirmed that the same reported event, product had already been entered and captured under pi 2358937.Based on this update, this record 2360808 along with associated children will be cancelled due this duplicate entry.Refer to pi 2358937 for the continuation of the complaint process of the alleged issue associated with the subject complaint device.
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Event Description
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It was reported that the coil (subject device) experienced difficulty advancing from the distal tip of the microcatheter and had fractured during use.Upon attempt of removal of microcatheter appeared to be protruded and occluded the vessel.The microcatheter was removed and the physician replaced the microcathter and used a stent to adjust the protruded coil to return blood flow.The procedure completed without clinical consequences to the patient.
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Search Alerts/Recalls
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