CROSSER IQ ULTRASONIC

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED. THE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) ARE ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CROSSER IQ CATHETER. DURING THE PROCEDURE, THE CATHETER WAS DISCONTINUED DUE TO POSSIBLE DAMAGE TO THE TIP AND THE END POINT. IT WAS LATER CONFIRMED THAT THE TIP, END POINT AND SHAFT WERE DETACHED FROM THE ADHESIVE, AND NO COMPLETE SEPARATION WAS OBSERVED. THERE WAS NO REPORTED PATIENT INJURY.