CROSSER

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE, ONE 14S CROSSER CTO RECANALIZATION CATHETER WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, NO ANOMALIES NOTED TO TRANSDUCER HANDLE, SALINE HUB, AND MARKER BAND IS PRESENT BUT HAD PEELING OVER IT AS NOTED UNDER MICROSCOPE EXAMINATION. NO OTHER ANOMALIES NOTED. UPON FUNCTIONAL EVALUATION, THE CROSSER WAS CONNECTED TO THE CROSSER GENERATOR AND FLOWMATE INJECTOR WITHOUT ISSUE. THE DISTAL TIP OF THE CATHETER SHAFT WAS PRESSED AGAINST THE END OF A PLASTER TILE; THE DEVICE ACTIVATED AND WAS ABLE TO PENETRATE THE TILE WITH NO ISSUES. DURING FUNCTIONAL TESTING, NO ABNORMAL NOISES WERE HEARD. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED ACTIVATION PROBLEM AS THE DEVICE WAS CONNECTED TO THE GENERATOR AND FLOWMATE INJECTOR WITHOUT ISSUE, THE DEVICE WAS ABLE TO PENETRATE THE PLASTER TILE WHILE ACTIVATION AND NO ABNORMAL NOISES WERE HEARD. HOWEVER, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELED AS THE PEELING OVER THE MARKERBAND WAS NOTED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ACTIVATION PROBLEM AND IDENTIFIED PEELED COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. IT IS UNKNOWN WHETHER PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. 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

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER CATHETER IN A CASE OF SFA DISTAL CALCIFICATION. PRIOR TO THE PROCEDURE, AN IN VITRO TEST WAS PERFORMED, IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY FAILED TO VIBRATE. WHEN THE USER TRIED TO RECONNECT IT, THERE WAS NO VIBRATION. IT WAS FURTHER REPORTED THAT A NEW CATHETER WAS INSERTED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONTACT.