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 medical procedure, the hospital technician accidentally touched and contaminated the indigo system cat3 aspiration catheter (cat3) upon removal from the packaging.The reported issue occurred prior to use and therefore, the cat3 was not used in the procedure.The procedure was completed using a new indigo system cat5 aspiration catheter (cat5).
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