| Reason for the Action |
Philips has been informed of cases where physicians, during “radial-to-peripheral” procedures (radial access), have used a Digital IVUS Catheter without the appropriate sheath and/or guide catheter; this inappropriate use could lead to failure to provide adequate support for manoeuvring the guidewire and catheter to peripheral vessels.
When using a short radial artery sheath with a Visions PV.014P Digital IVUS Catheter over an .014 guide wire, for example, the user may experience resistance while loading and removing the catheter. If the user removes the wire and catheter together without forcing, there should be no expected harm to the patient.
However, if the user continues the procedure despite resistance, the catheter and guide wire could get tangled, potentially requiring further intervention. In some cases, longer sheaths can assist, but surgical removal may be necessary.
There have been 7 adverse events requiring additional intervention. No deaths have been reported for this problem. |