The product was disposed of by the hospital and is no longer available for return.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 thrombectomy procedure, while the hospital staff was opening a new indigo system aspiration catheter 6 (cat6), the cat6 inadvertently fell from its packaging and was contaminated.The cat6 became contaminated prior to use and therefore, was not used in the procedure.The procedure was completed using a new indigo system cat5 aspiration catheter (cat5).
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