|
This case was reviewed and investigated according to the manufacturer's policy.It was reported during a diagnostic peripheral procedure, when the manufacturer's catheter was removed the physician noticed a "wire" coming from the catheter tip and it appeared a piece of the wire from the catheter was exposed outside the catheter.The scrub tech did not notice any wire when placing the catheter in the patient.No loss of image quality was reported.There was no known harm to the patient.Vessel: greater than 90% occlusion of the left renal vain.Occlusion due to artery pressing against vain.None tortuous vessel.No plaque.Additional information obtained indicated device was never stuck.The device was removed over the wire as normal with the only difference being that the physician reported feeling it "get hung up a little" as he pulled it through the sheath.No additional intervention was performed or required and no patient event.Patient was discharged as expected.Visual and microscopic inspection of the returned device was performed pre- and post-decontamination.There was a tear extending from the guide wire exit port to past the core wire in the distal shaft, the core wire was exposed, blood was present in the outer lumen and the core wire, the distal shaft was folded in on itself and skewered on the core wire.There were air bubbles in the proximal fillet and the weld legs were uneven in alignment.The tear measured to extend 40 mm distal to the guide wire exit port.No additional observations were made.The device was recognized by the imaging system and produced a clear and constant image.The probable cause of the failure is damage during use as evidenced by the tear along the distal shaft and blood in the outer lumen.Strain, impact, and forces associated with use and handling can affect the integrity of the device.It could not be conclusively determined when the cause of the failure occurred.The instructions for use (ifu) precautions the visions pv.014p device is a delicate scientific instrument and should be treated as such.Always observe the following precautions: protect the catheter tip from impact and excessive force.When inserting the guide wire both catheter and wire must be straight with no bends or kinks, or damage to inner lumen may occur.Do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.If binding occurs outside of the patient, remove the catheter and do not use.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.Additionally, complaints are monitored by monthly complaint review board process.This event is being reported as there is a potential for harm if the event were to recur.
|
