Patient age, date of birth, and weight are unavailable.The device was returned to the manufacturer for evaluation.During visual evaluation of the device, the reported damage was confirmed.The damaged area of the catheter jacket extends 3.25 inches from the distal port.The tear starts at the port, and the nature of the damage is indicative of damage caused by a guidewire.It appeared that the user missed insertion of the guidewire into the port and subsequently damaged the jacket.
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It was reported that following a vascular intervention procedure, it was discovered that there was a tear in the catheter outer jacket.The procedure had been completed successfully, and the patient was not impacted.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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