Model Number 7110-0415-A2 |
Device Problems
Stretched (1601); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2021 |
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 implanted in the patient and not returned to the manufacturer for analysis.The alleged product issue could not be confirmed.
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Event Description
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It was reported that during treatment of a ruptured aneurysm, an embolization coil implant did not detach.It then stretched, and a portion of the stretched coil remains implanted in the patient.It was the physician's opinion that the stretched segment would not be "a major contributing issue for the outcome of the patient." there was no reported patient injury or intervention.The patient's current status is unknown.
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Manufacturer Narrative
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Additional information received stated that the implant coil stretched down to the arm and that the ruptured aneurysm being treated was considered high grade and acute.
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Search Alerts/Recalls
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