(b)(4).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.This report is associated with mfr report number: 3005168196-2017-01400.The hospital discarded the device.
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The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician felt resistance advancing a ruby coil through the tip of a non-penumbra microcatheter; consequently, the ruby coil became kinked.The ruby coil and microcatheter was therefore removed and, upon removal, it was found that the microcatheter was kinked.A new microcatheter was placed, and the technician accidentally kinked a second ruby coil while advancing it into the microcatheter; therefore, the ruby coil was removed and re-sheathed.The ruby coil became sticky within the introducer sheath because it had not been cleaned upon removal; therefore, it could not be advanced out of the introducer sheath and into the microcatheter.The procedure was completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
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