Model Number 100256HS3D-V-A2 |
Device Problems
Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A search for non-conformances associated with the reported 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 returned to the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
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Event Description
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It was reported that during a coil embolization of an aneurysm, the coil encountered some resistance within the microcatheter.The coil stretched and detached within the microcatheter during positioning.The coil system and microcatheter were removed together without incident.The patient was reported in good condition.There was no reported patient injury or sequela.
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Manufacturer Narrative
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The results of the investigation are ongoing and dependent on the investigation of a concomitant device.
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Manufacturer Narrative
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The investigation of the returned coil system found the pusher and implant to be severely stretched and broken.The returned headway 17 microcatheter was investigated under x-ray and found the broken distal end of the pusher stuck inside with a part of the stretched implant coil.During the investigation of the returned microcatheter, the distal end of the pusher was carefully removed and found the marker band to be attached to the pusher's heater coil with dry blood contamination.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
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Search Alerts/Recalls
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