CROSSER

Description of Event or Problem

ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE CTO CROSSER CATHETER TO TREAT ENDOVASCULAR THROMBECTOMY. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE SALINE WAS ALLEGEDLY RELEASED FROM THE INJECTOR TO REMOVE AIR FROM THE IRRIGATION LUMEN, CAUSING A WATER LEAK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE, ONE 14S CROSSER CATHETER WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, NO ANOMALIES NOTED TO TRANSDUCER HANDLE OR SALINE HUB. DRY RESIDUE WAS NOTED WITHIN THE STRAIN RELIEF. MARKER BAND WAS PRESENT AND UNDAMAGED. NO ANOMALIES WERE NOTED TO THE DISTAL TIP. UPON FUNCTIONAL EVALUATION, THE DEVICE WAS CONNECTED TO THE CROSSER GENERATOR AND FLOWMATE INJECTOR WITHOUT ISSUE. THE DEVICE ACTIVATED AND IT WAS NOTED THAT SALINE WAS LEAKING FROM THE DISTAL END OF THE STRAIN RELIEF. UPON MICROSCOPIC EVALUATION, IT WAS NOTED THERE WAS A TEAR ON THE OUTER CATHETER WHICH MAY HAVE BEEN THE SOURCE OF THE LEAK. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE LEAK AS THE SALINE WAS LEAKING FROM THE DISTAL END OF THE STRAIN RELIEF. ALSO, THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED TEAR AS THE TEAR WAS NOTED ON THE OUTER CATHETER. A DEFINITIVE ROOT CAUSE FOR THE REPORTED LEAK 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.