CROSSER IQ ULTRASONIC

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING CROSSER CATHETER IN SUPERFICIAL FEMORAL ARTERY (SFA) TREATMENT WAS PERFORMED VIA A CONTRALATERAL APPROACH. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE ADVANCED APPROXIMATELY 3 CM FROM THE TIP OF THE CATHETER WHEN THE CTO WAS 1 CM AWAY, PREVENTING THE CROSSER FROM ADVANCING. A NEW CATHETER WAS THEN INSERTED, AND THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY.

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: ONE CROSSER IQ ULTRASONIC CTO DEVICE WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, NO ANOMALIES NOTED TO THE HANDLE OR SALINE HUB. MARKER BAND IS PRESENT AND UNDAMAGED. UNDER MICROSCOPIC EXAMINATION, THERE WAS PEELING OVER THE MARKER BAND. IN ADDITION, THE IRRIGATION PORT APPEARED TO BE USUALLY LARGER THAN USUAL. UPON FUNCTIONAL EVALUATION, A GUIDEWIRE WAS INSERTED AND RETRACTED WITHOUT ISSUE. NO OTHER FUNCTIONAL TESTING WAS PERFORMED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE TO ADVANCE AS THE CONDITION FOR THE ADVANCEMENT OF THE CATHETER CANNOT BE RECREATED AS FAILURE HAPPENED IN THE PATIENT. HOWEVER, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED PEELING AS THE PEELING OVER THE MARKERBAND WAS NOTED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO ADVANCE AND IDENTIFIED PEELING COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR 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.