CROSSER

Additional Manufacturer Narrative

H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE CROSSER CTO RECANALIZATION CATHETERS PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE CROSSER CTO RECANALIZATION CATHETERS PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: ONE 14S CROSSER CATHETER WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, IT WAS NOTED THERE WAS SHEATH OVER THE MARKER BAND, AND THE CATHETER HAD SLIGHT PINCHING DISTAL TO THE TIP. THERE WAS A SLIGHT CURVATURE TO THE DISTAL ENDS OF THE CATHETER. NO ANOMALIES NOTED TO THE SALINE LUER OR THE HANDLE. UPON FUNCTIONAL EVALUATION, THE CROSSER WAS CONNECTED TO THE CROSSER GENERATOR AND FLOWMATE INJECTOR WITHOUT ISSUE. THE DEVICE WAS ACTIVATED AND EXHIBITED MISTING AS NORMAL FUNCTION. DURING FUNCTIONAL TESTING, NO ABNORMAL NOISES WERE HEARD. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED FLUSHING PROBLEM AS THE CROSSER WAS CONNECTED TO THE GENERATOR AND INJECTOR WITHOUT ISSUE; AND THE DEVICE WAS ACTIVATED AND EXHIBITED MISTING AS NORMAL FUNCTION. ALSO, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELING OVER THE MARKER BAND WAS NOTED DURING MICROSCOPIC TEST. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FLUSHING PROBLEM AND IDENTIFIED PEELING COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED SECTION A THROUGH F ¿ THE INFORMATION PROVIDED 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 CROSSER DEVICE. PRIOR TO THE PROCEDURE, WHILE CONNECTING THE CROSSER AN ATTEMPT WAS MADE TO FLUSH THE INSIDE OF THE CATHETER BUT FAILED BECAUSE THE SALINE WAS NOT AVAILABLE. THE PROCEDURE WAS COMPLETED WITH NEW CATHETER, AND IT WORKED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT CONTACT.