A philips representative reported that during preoperation for a peripheral atherectomy procedure, the integrity of the turbo-elite atherectomy 414-151 catheter was questioned.
The device was removed from the procedure and a second turbo-elite atherectomy 414-151 catheter was used instead.
Procedure completed successfully, with no harm to the patient or user.
The device was returned to the manufacturer for evaluation and it was determined on 30-nov-2018, that the catheter had exposed laser fibers outside of the catheter sheath.
This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.
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