PressureWire¿

Description of Event or Problem

It was reported that a procedure was performed to treat a lesion in the Left Anterior Descending (LAD) artery. A Pressurewire X wireless guidewire was noted to be very difficult to remove from the dispenser coil. It was also noted that the Pressurewire X could not connect to the Coroventis system, displaying an orange light. The Pressurewire X was not inserted into the patient. Another Pressurewire X was used and the transmitter displayed an orange light and the Pd values were noted to be around 300. A non-Abbott device was used to complete the procedure. There were no adverse patient effects and no clinically significant delay.Returned device analysis showed that there was a break was observed at the distal tube/proximal tube junction of the first device. No additional information was provided.

Additional Manufacturer Narrative

A visual inspection was performed on the returned device. The reported difficulty to remove was not confirmed. There were multiple bends and kinks noted to the PressureWire. The distal tube was twisted just proximal to the sensor jacket. A break was observed at the distal tube/proximal tube junction. The reported communication problem was confirmed. Production record and Corrective and Preventative Actions (CAPA) reviews were performed and revealed one related Complaint Assessment CAPA. The investigation determined that the reported communication or transmission problem was a result of damage to the internal components which likely occurred during the difficulty removing from the dispenser coil. Although the reported difficulty removing from the dispenser coil was unable to be confirmed, a potential product quality issue has been identified related to difficulty removing the PressureWire from the dispenser coil. The issue is being addressed per internal operating procedures. Abbott Vascular will continue to trend the performance of these devices.