OKAY MEG

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, AND THE INVESTIGATION WAS UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED PROBLEM. THE REPORTED EVENT MAY HAVE BEEN CAUSED BY LEAKAGE FROM THE HEMOSTASIS VALVE, DUE TO THE INFLUENCE OF THE ANGLE OF THE COMBINED DEVICE INSERTED INTO THE PRODUCT OR DUE TO THE OPENER WAS OPENED BY MISTAKE, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED. NO ABNORMALITIES WERE FOUND ON THE PRODUCTION RECORDS. THE INSTRUCTIONS FOR USE (IFU) PROVIDE GENERAL INSTRUCTIONS FOR USE, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND INFORMATION TO MAKE YOU AWARE OF POTENTIAL COMPLICATIONS AND OTHER EVENTS SIMILAR TO THIS EVENT THAT MAY OCCUR. THIS REPORT DOES NOT IMPLY AN ADMISSION BY ANYONE THAT THE PRODUCTS MENTIONED IN THIS REPORT ARE DEFECTIVE. HOWEVER, SINCE WE HAVE NOT BEEN ABLE TO CONFIRM THE ACTUAL PRODUCT, WE CANNOT DENY THAT THE BLOOD LEAKAGE OCCURRED BECAUSE THE PRODUCT WAS DAMAGED, SO WE ARE SUBMITTING THIS REPORT CONSERVATIVELY.

Description of Event or Problem

IT WAS REPORTED THAT BLOOD LEAKED FROM THE HEMOSTASIS VALVE DURING USE AT FRACTIONAL FLOW RESERVE . THEN THE DEVICE WAS USED AS IS AND THE PROCEDURE WAS CONTINUED. NO COMPLICATIONS WERE REPORTED.