GRAFTMASTER

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 3.5X26MM AND 2.8X26MM GRAFTMASTERS FAILED TO CROSS DUE TO ANATOMY. THEREFORE, BALLOON ANGIOPLASTY WAS PERFORMED SUCCESSFULLY TREAT THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO PROCEDURAL CIRCUMSTANCES. IT IS LIKELY THE INTERACTION WITH THE HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES.