Peripherally inserted central catheters (PICC lines): Serious adverse events with the use of PICC lines, update 2

Updated web advisory

24 October 2008

The Therapeutic Goods Administration is investigating reports of adverse events associated with the use of Peripherally Inserted Central Catheter (PICC) lines in Queensland. The reports follow 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 regards these reports as serious and is investigating them as a matter of urgency. The TGA is liaising with Queensland Health on the issue as well as with other international regulatory agencies to determine whether this is a worldwide issue.

In the interim the Australian sponsor of the Arrow product (Mayo Healthcare) is undertaking a Recall for Product Correction to update the Instructions for Use supplied with the catheters.

The TGA is also investigating 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.

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.

The TGA is urgently investigating the incidents reported by Queensland Health to determine whether the problem is a device problem or whether it represents a failure to observe the manufacturer's instructions. Appropriate corrective action/safeguards will be determined once the careful examination of this and similar products has been completed.

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.