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Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Information (3190)
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Event Date 07/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The device was not returned.
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Event Description
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The patient was undergoing a coil embolization procedure in the subclavian artery using ruby coils.During the procedure, a ruby coil unintentional detached.Additional medical intervention was required to remove the detached ruby coil from the patient.It is unknown if there was any adverse effect to the patient.
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Manufacturer Narrative
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Please note that the device was initially available for return; however, additional information obtained confirmed that the device was not available for return.The report was therefore corrected accordingly.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
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Search Alerts/Recalls
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