ECRI issues alert on some thoracic catheters

An independent health care safety watchdog has issued a critical alert to hospitals regarding a potential threat to patient safety caused by some thoracic catheters in Pharmaseal Thoracentesis Trays distributed by McGaw Park, IL-based Allegiance Healthcare Corp.

The catheters, which are used to aspirate fluid from the lungs, may be brittle and can fragment in the patient’s pleural space, according to ECRI, a medical device research organization in Plymouth Meeting, PA. Because the catheter is exposed only after it is inserted into the patient, the health care provider cannot examine the flexibility or strength of the catheter before insertion, complicating efforts to spot the defective products, says Mark E. Bruley, vice president for accident and forensic investigation at ECRI.

Possible complications resulting from fragmented catheters are foreign-body reactions, infection, and the need for surgery to remove the fragments. ECRI’s Accident and Forensic Investi-gation Group discovered the problem when a member hospital requested an investigation following the surgical removal of a catheter fragment after aspiration of a patient’s parietal cavity. ECRI’s team of investigators determined that three more catheters from trays with the same lot number L1N094, were found to be broken or brittle. Bruley says another instance has been reported to the U.S. Food and Drug Administration with the same Pharmaseal thoracentesis catheters but with lot number L1K058.

"The problem may be more extensive than those particular lots," he says. "We’ll know more once Allegiance Healthcare has conducted a wider investigation of the catheters."