INDEFLATOR

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED MATERIAL SEPARATION WAS 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, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. IT IS POSSIBLE THAT INADVERTENT MISHANDLING DURING UNPACKAGING AND/OR DURING PREPARATION FOR USE (SUCH AS TAPPING INDEFLATOR TO CLEAR AIR BUBBLES) RESULTED IN THE REPORTED MATERIAL SEPARATION WHERE THE HOSE FITTING SEPARATED FROM THE SYRINGE HOUSING; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX ARTERIES WITH MILD TORTUOSITY. DURING THE PROCEDURE TWO CO-PILOT INDEFLATORS WERE BEING USED; HOWEVER, THE TUBING ON ONE OF THE INDEFLATORS BECAME DETACHED DURING USE. THEREFORE, ANOTHER INDEFLATOR WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.