Model Number 100520H2HS-V-A2 |
Device Problems
Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/04/2021 |
Event Type
Injury
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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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.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 upon removing the delivery pusher from the dispenser hoop, the delivery pusher was observed to be bent.The device passed the pre-test.During positioning, the implant coil detached from the delivery pusher.The coil was removed successfully using an endovascular snare.The patient was reported to be "good." there was no reported patient injury or sequela.
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Search Alerts/Recalls
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