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 thrombectomy procedure, the hospital staff was unsure whether or not part of the indigo system aspiration catheter 6 (cat6) touched something non-sterile upon removal from the sterile pouch.Therefore, the cat6 was not used in the procedure.The procedure was successfully completed using a new cat6.
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