SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR CATHETER AND A PIECE OF PLASTIC WAS STUCK TO THE TIP OF THE CATHETER WHICH WAS DISCOVERED INSIDE OF THE PACKAGING. THE CONSISTENCY OF THE MATERIAL WAS LIKE A PRICE TAG/STICKER THAT COULD NOT BE REMOVED. THERE WAS NO DAMAGE TO THE OUTER BOX OR PACKAGING. THE PRIMARY PACKING WAS NOT REMOVED BEFORE PROCEDURE. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED TO STERILMED FOR EVALUATION. STERILMED PERFORMED VISUAL INSPECTION AND FUNCTIONAL TEST ON THE RETURNED DEVICE. THE DEVICE WAS INSPECTED AND FOUND WITHOUT THE SM TAG NUMBER; A WHITE STICKY MATERIAL WAS FOUND ON THE SHAFT AREA 30.5" FROM THE HANDLE. DUE TO RETURNED PRODUCT CONDITIONS, FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED TO DETERMINE THE COMPOSITION OF THE FOREIGN MATTER FOUND AND CONCLUDES THAT IT IS COMPOSED OF CELLULOSE. AT THIS TIME, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS CONDITION, HOWEVER BASED ON THE INFORMATION PROVIDED, THE CONDITION REPORTED MAY HAVE ORIGINATED IN SOME PLACE EXTERNAL TO THE MANUFACTURING ENVIRONMENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. AS PART OF STERILMED¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER'S REF. NO: (B)(4).