Peripherally inserted central catheters (PICC lines): Serious adverse events with the use of PICC lines, update 3

Updated web advisory

13 November 2008

The Therapeutic Goods Administration has investigated reports of adverse events associated with the use of Peripherally Inserted Central Catheter (PICC) lines in Queensland. The reports followed an initial investigation of an incident involving a 5 year old child at Townsville Hospital.

On 7 October 2008 the Therapeutic Goods Administration (TGA) received a preliminary adverse event report from a hospital in Queensland of an incident that occurred during a procedure to insert a peripherally inserted central venous catheter line, commonly referred to as a PICC line. The TGA has subsequently received a number of additional reports from Queensland of similar events associated with the use of the device made by Arrow International Inc.

The TGA regarded these reports as serious and investigated them as a matter of urgency. The TGA liaised with Queensland Health on the issue as well as with other international regulatory agencies to determine whether this is a worldwide issue.

As an interim measure the Australian sponsor of the Arrow product (Mayo Healthcare) undertook a Recall for Product Correction to update the Instructions for Use supplied with the catheters.

The TGA also investigated other brands of PICC devices in the Australian market to determine whether the issues raised in the incident reports are relevant to other brands of catheters.

This investigation has now been completed. The results of this investigation have shown that there are no inherent flaws in any of the PICC lines. However, as with all medical devices it is important that Instructions for Use are carefully followed. The TGA has identified opportunities for improvements that can be made to the current label warnings and Instructions for Use accompanying all of the devices. The TGA believes that such improvements will assist users of the devices and has requested the sponsors of the devices to undertake these changes.

Background

A peripherally inserted central catheter (PICC line) is a form of intravenous access that can be used for a prolonged period of time, eg for long chemotherapy regimens or extended antibiotic therapy. A PICC line is inserted with the aid of a removable guide wire. In several of the reports the guidewire had inadvertently been cut and a portion of it had migrated into the patient's circulatory system.

The TGA has investigated similar incidents previously, and has also issued general warnings against cutting of catheter guidewires. Previous investigations conducted by the TGA have revealed that the type of events described can occur when the instructions for use supplied with these types of catheters are not strictly followed. The TGA has issued safety advisories on three separate occasions on this issue, most recently in 2005. At the time the TGA's advice was to avoid shortening the catheter wherever possible, but if necessary to do so, the manufacturer's instructions should be very carefully followed.

It is important that users of medical devices report problems to the Medical Device Incident Report Investigation Scheme at the TGA promptly and also to the supplier of the device.