The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital disposed of the device.
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The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, while attempting to insert a cat6 through another manufacturer¿s sheath, the physician experienced resistance and inadvertently smashed the tip of cat6.Therefore, it was removed.The physician then switched to a new sheath and the procedure was successfully completed using a new cat6.There was no report of an adverse effect to the patient.
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