A peripheral vascular intervention case commenced using a spectranetics turbo elite laser atherectomy catheter.During preparation for use, the physician reported having trouble feeding the guidewire through the guide port of the device.The guide port eventually broke causing damage to the catheter.After damaging the catheter, the physician stated a light could been seen coming out through the outer jacket of the device.The procedure was successfully completed with a new device with no reported patient injury.This event is being reported due to the potential for exposure to manufacture materials and inadvertent laser energy/radiation exposure.
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In the initial mdr submitted for this event, it was reported that "the physician reported having trouble feeding the guidewire through the guide port of the device.The guide port eventually broke causing damage to the catheter." upon further discussion on 25 june 2020 with the philips representative who was present at the case, it was discovered that the damage to the device was not caused by a guidewire.Reportedly, although the breach to the outer jacket of the device may have been at the area of the laser catheter where the guide wire is inserted (cannot confirm because the device is not being returned), an outer sheath (manufacturer unknown) was being used in a contralateral approach to treat the patient.It was reported that the physician was able to get through the first portion of the outer sheath but at the bifurcate, it became difficult to advance the device.It was at that time that the device was discovered to be damaged.
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