The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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During preparation for a coil embolization procedure, the hospital staff noticed that half of the ruby coil was hanging out its introducer sheath upon removal from the dispenser hoop.The ruby coil was noticed prior to use and therefore, was not used in the procedure.The procedure was successfully completed using a new ruby coil.
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