The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.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: 3005168196-2017-01462.The hospital disposed of the device.
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During preparation for a thrombectomy procedure, the indigo system separator 8 (sep8) and indigo system aspiration catheter 8 (cat8) slipped off the table and became contaminated.The sep8 and cat8 became contaminated prior to use and therefore, were not used for the procedure.The procedure was completed using a new sep8 and cat8.
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