PRESSUREWIRE¿

Description of Event or Problem

IT WAS REPORTED THAT THE PRESSUREWIRE X WIRELESS DEVICE WAS REMOVED FROM THE PACKAGE WHEN IT WAS NOTED AS KINKED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PRODUCT RETURN IDENTIFIED A BREAK IN THE PROXIMAL TUBE OF THE PRESSUREWIRE.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED KINK WAS ABLE TO BE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED KINK APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE RETURNED DEVICE WAS NOTED TO BE KINKED AND BENT IN MULTIPLE LOCATIONS, WHICH RESULTED IN THE REPORTED AND CONFIRMED DEFORMATION DUE TO COMPRESSIVE. ONE OF THE KINKS CAUSED A BREAK TO THE PROXIMAL TUBE OF THE GUIDEWIRE, WHICH LIKELY RESULTED FROM CONTINUED HANDLING OF THE KINK. IN THIS CASE, IT IS LIKELY THAT THE GUIDEWIRE DAMAGE (KINKS, BENDS, AND PROXIMAL TUBE BREAK) WAS CAUSED BY THE PREPARATION HANDLING OR GUIDEWIRE REMOVAL TECHNIQUES EMPLOYED. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.