Model Number VFC101540-V-A2 |
Device Problems
Device-Device Incompatibility (2919); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2023 |
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 returned to the manufacturer for evaluation.The investigation is ongoing.The instructions for use identifies premature coil separation as a potential complication associated with use of the device.
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Event Description
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It was reported that an embolization coil implant encountered resistance during advancement in a microcatheter.The distal loops of the coil exited the catheter when the operator decided to remove the device.The pusher was removed but the coil remained behind, partially deployed and partially within the catheter.There was no patient injury or intervention.
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Manufacturer Narrative
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The investigation of the returned coil system found the implant returned separated from the pusher with deformed loops.The pusher was not returned for evaluation.The implant's monofilament was found to experience a tensile break based on the profile of the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The returned microcatheter was found to be kinked at multiple locations along the distal section, which would result in resistance when advancing the coil system through the lumen as described in the reported complaint.The physical evaluation of the devices could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the devices experiencing forces over specification.
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Event Description
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No new information.
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Search Alerts/Recalls
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